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Tretinoin 0.04 % Gel 20 Gm

  • Manufacturer Name : BAUSCH & LOMB
  • MFG # : 68682051492
  • NDC : 68682051492
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
316938 UN
$215.01
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tretinoin microspheres TOPICAL GEL (GRAM

Product Properties:

Description -
Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind NR
DESI2 Drug Ind -
DESI2 Drug Ind NR
Drug Category I
Drug Category NJ
Drug Category NJ
Drug Type Code I
Drug Type Code I
Drug Type Code 1
FDA Approval Date 05/10/2002
FDA Approval Date 06/15/2002
FDA Approval Date 06/15/2002
FDA Therap Equiv GM
FDA Therap Equiv GM
FDA Therap Equiv NR
HCPCS -
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date -
Market Entry Date 06/15/2002
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date 1
Termination Date -
Unit GM
Unit 20
Unit 20
Units Per Pkg 05/10/2002
Units Per Pkg 05/10/2002
Units Per Pkg 20
Active Ingredients 10766 tretinoin microspheres 302794
Active Ingredients 10766 tretinoin microspheres 302794
Active Ingredients 10766 tretinoin microspheres 302794
AHFS Class 84160000 CELL STIMULANTS AND PROLIFERANTS
AHFS Class 84160000 CELL STIMULANTS AND PROLIFERANTS
AHFS Class 84160000 CELL STIMULANTS AND PROLIFERANTS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form GEL (GRAM)
Dose Form GEL (GRAM)
Dose Form GEL (GRAM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 50417 tretinoin microspheres TOPICAL GEL (GRAM) 0.04 %
Gen Code and Des 50417 tretinoin microspheres TOPICAL GEL (GRAM) 0.04 %
Gen Code and Des 50417 tretinoin microspheres TOPICAL GEL (GRAM) 0.04 %
Inactive Ingredients 2468 propylene glycol 57556; 3192 benzyl alcohol 100516; 3785 edetic acid 60004
Inactive Ingredients 2468 propylene glycol 57556; 3192 benzyl alcohol 100516; 3785 edetic acid 60004
Inactive Ingredients 2468 propylene glycol 57556; 3192 benzyl alcohol 100516; 3785 edetic acid 60004
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 0.04%
Strength 0.04%
Strength 0.04%
Common Brand Name COMMON BRAND NAME(S): Retin-A
Common Brand Name COMMON BRAND NAME(S): Retin-A
Common Brand Name COMMON BRAND NAME(S): Retin-A
Drug Interaction DRUG INTERACTIONS: See also Precautions section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Avoid using other skin products that are harsh, irritating, or drying on the treated area. These products include hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotion), medicated or abrasive soaps or cleansers, soaps and cosmetics with a strong drying effect (such as alpha hydroxy acids, glycolic acid), and products containing sulfur, resorcinol, or salicylic acid. Benzoyl peroxide can be very irritating and may decrease the effectiveness of tretinoin if the two products are applied at the same time. Talk with your doctor or pharmacist about the safe use of prescription and non-prescription benzoyl peroxide products.
Drug Interaction DRUG INTERACTIONS: See also Precautions section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Avoid using other skin products that are harsh, irritating, or drying on the treated area. These products include hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotion), medicated or abrasive soaps or cleansers, soaps and cosmetics with a strong drying effect (such as alpha hydroxy acids, glycolic acid), and products containing sulfur, resorcinol, or salicylic acid. Benzoyl peroxide can be very irritating and may decrease the effectiveness of tretinoin if the two products are applied at the same time. Talk with your doctor or pharmacist about the safe use of prescription and non-prescription benzoyl peroxide products.
Drug Interaction DRUG INTERACTIONS: See also Precautions section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Avoid using other skin products that are harsh, irritating, or drying on the treated area. These products include hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotion), medicated or abrasive soaps or cleansers, soaps and cosmetics with a strong drying effect (such as alpha hydroxy acids, glycolic acid), and products containing sulfur, resorcinol, or salicylic acid. Benzoyl peroxide can be very irritating and may decrease the effectiveness of tretinoin if the two products are applied at the same time. Talk with your doctor or pharmacist about the safe use of prescription and non-prescription benzoyl peroxide products.
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 24
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 20
Drug Form Pack Size 20
Drug Form Pack Size 20
Form GELATIN
Form GELATIN
Form GELATIN
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code NT3 NON-ANTINEOPLASTIC DRUGS THAT PRIMARILY HAVE ADVERSE REPRODUCTIVE EFFECTS
NIOSH Code NT3 NON-ANTINEOPLASTIC DRUGS THAT PRIMARILY HAVE ADVERSE REPRODUCTIVE EFFECTS
NIOSH Code NT3 NON-ANTINEOPLASTIC DRUGS THAT PRIMARILY HAVE ADVERSE REPRODUCTIVE EFFECTS
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 20
Unit Size 20
Unit Size 20
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist Wash your hands before applying this medication. Gently clean the affected skin with a mild or soapless cleanser and pat dry. Use your fingertips to apply a small amount of medication (about the size of a pea) in a thin layer as directed by your doctor, usually once daily at bedtime. A gauze pad or cotton swab can be used to apply the liquid. For some preparations, you should wait 20-30 minutes after cleaning your face before applying this medication. Consult the label directions, the Patient Information Leaflet, or your pharmacist if you have any questions. Use this medication on the skin only. Do not apply to the inner lip area or inside the nose/mouth. Do not apply to cut, scraped, sunburned, or eczema-affected skin. Avoid getting this medication in your eyes. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes. During the first few weeks of using tretinoin, your acne might appear worse because the medication is working on pimples forming inside the skin. It may take up to 8-12 weeks to notice results from this medication. Use it regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more frequently than recommended. Your skin will not improve any faster, and it will increase the risk of developing redness, peeling and pain. This medication is available in different strengths and forms (such as gel, cream, solution). The best type of medication for you to use will depend on the condition of your skin and your response to therapy. Tell your doctor if your condition lasts or gets worse.
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist Wash your hands before applying this medication. Gently clean the affected skin with a mild or soapless cleanser and pat dry. Use your fingertips to apply a small amount of medication (about the size of a pea) in a thin layer as directed by your doctor, usually once daily at bedtime. A gauze pad or cotton swab can be used to apply the liquid. For some preparations, you should wait 20-30 minutes after cleaning your face before applying this medication. Consult the label directions, the Patient Information Leaflet, or your pharmacist if you have any questions. Use this medication on the skin only. Do not apply to the inner lip area or inside the nose/mouth. Do not apply to cut, scraped, sunburned, or eczema-affected skin. Avoid getting this medication in your eyes. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes. During the first few weeks of using tretinoin, your acne might appear worse because the medication is working on pimples forming inside the skin. It may take up to 8-12 weeks to notice results from this medication. Use it regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more frequently than recommended. Your skin will not improve any faster, and it will increase the risk of developing redness, peeling and pain. This medication is available in different strengths and forms (such as gel, cream, solution). The best type of medication for you to use will depend on the condition of your skin and your response to therapy. Tell your doctor if your condition lasts or gets worse.
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist Wash your hands before applying this medication. Gently clean the affected skin with a mild or soapless cleanser and pat dry. Use your fingertips to apply a small amount of medication (about the size of a pea) in a thin layer as directed by your doctor, usually once daily at bedtime. A gauze pad or cotton swab can be used to apply the liquid. For some preparations, you should wait 20-30 minutes after cleaning your face before applying this medication. Consult the label directions, the Patient Information Leaflet, or your pharmacist if you have any questions. Use this medication on the skin only. Do not apply to the inner lip area or inside the nose/mouth. Do not apply to cut, scraped, sunburned, or eczema-affected skin. Avoid getting this medication in your eyes. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes. During the first few weeks of using tretinoin, your acne might appear worse because the medication is working on pimples forming inside the skin. It may take up to 8-12 weeks to notice results from this medication. Use it regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more frequently than recommended. Your skin will not improve any faster, and it will increase the risk of developing redness, peeling and pain. This medication is available in different strengths and forms (such as gel, cream, solution). The best type of medication for you to use will depend on the condition of your skin and your response to therapy. Tell your doctor if your condition lasts or gets worse.
Missed Dose MISSED DOSE: If you forget to use this medication, use it as soon as you remember if you remember the same day. If you don't remember until morning, wait until your next dose is scheduled.
Missed Dose MISSED DOSE: If you forget to use this medication, use it as soon as you remember if you remember the same day. If you don't remember until morning, wait until your next dose is scheduled.
Missed Dose MISSED DOSE: If you forget to use this medication, use it as soon as you remember if you remember the same day. If you don't remember until morning, wait until your next dose is scheduled.
Notes NOTES: Do not share this medication with others. Cosmetics may be used, but clean skin thoroughly before applying the medication. Some cosmetics and soaps may worsen your acne. Moisturizers may be safe to use. When buying cosmetics, moisturizers or other skin care products, check the label for "non-comedogenic" or "non-acnegenic." These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too often or too vigorously can irritate your skin and worsen acne.
Notes NOTES: Do not share this medication with others. Cosmetics may be used, but clean skin thoroughly before applying the medication. Some cosmetics and soaps may worsen your acne. Moisturizers may be safe to use. When buying cosmetics, moisturizers or other skin care products, check the label for "non-comedogenic" or "non-acnegenic." These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too often or too vigorously can irritate your skin and worsen acne.
Notes NOTES: Do not share this medication with others. Cosmetics may be used, but clean skin thoroughly before applying the medication. Some cosmetics and soaps may worsen your acne. Moisturizers may be safe to use. When buying cosmetics, moisturizers or other skin care products, check the label for "non-comedogenic" or "non-acnegenic." These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too often or too vigorously can irritate your skin and worsen acne.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (tret-ih-NO-in)
Phonetic Pronunciation (tret-ih-NO-in)
Phonetic Pronunciation (tret-ih-NO-in)
Precautions PRECAUTIONS: Before using tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as fish proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Weather extremes such as wind or cold may also be irritating to the skin. Use sunscreen daily and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Wait until your skin has completely recovered from a sunburn before using tretinoin. Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product. If you have recently used products containing sulfur, resorcinol or salicylic acid, use tretinoin with caution. Wait until the effects of such products on the skin have decreased before using tretinoin. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before using tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as fish proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Weather extremes such as wind or cold may also be irritating to the skin. Use sunscreen daily and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Wait until your skin has completely recovered from a sunburn before using tretinoin. Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product. If you have recently used products containing sulfur, resorcinol or salicylic acid, use tretinoin with caution. Wait until the effects of such products on the skin have decreased before using tretinoin. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before using tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as fish proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Weather extremes such as wind or cold may also be irritating to the skin. Use sunscreen daily and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Wait until your skin has completely recovered from a sunburn before using tretinoin. Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product. If you have recently used products containing sulfur, resorcinol or salicylic acid, use tretinoin with caution. Wait until the effects of such products on the skin have decreased before using tretinoin. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Warmth or stinging may occur right after applying the medication. Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2 to 4 weeks of using the medication. These effects usually decrease with continued use. A daytime moisturizer may be helpful for very dry skin (see Notes). If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: blistering/crusting of the skin, severe burning/swelling of the skin, skin discoloration. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Warmth or stinging may occur right after applying the medication. Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2 to 4 weeks of using the medication. These effects usually decrease with continued use. A daytime moisturizer may be helpful for very dry skin (see Notes). If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: blistering/crusting of the skin, severe burning/swelling of the skin, skin discoloration. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Warmth or stinging may occur right after applying the medication. Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2 to 4 weeks of using the medication. These effects usually decrease with continued use. A daytime moisturizer may be helpful for very dry skin (see Notes). If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: blistering/crusting of the skin, severe burning/swelling of the skin, skin discoloration. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature. Gel preparations are flammable. Do not expose to heat or fire sources. Do not smoke during use. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature. Gel preparations are flammable. Do not expose to heat or fire sources. Do not smoke during use. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature. Gel preparations are flammable. Do not expose to heat or fire sources. Do not smoke during use. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells.
Uses USES: This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells.
Uses USES: This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells.

Frequently Asked Questions(FAQs)

The cost of TRETINOIN 0.04 % GEL 20 GM is $ 215.01.
TRETINOIN 0.04 % GEL 20 GM is manufactured by BAUSCH & LOMB.
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