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Tri-Luma Crm 30 Gm

  • Manufacturer Name : Galderma
  • MFG # : 00299595030
  • NDC : 00299595030
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
281624 UN
$423.16
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fluocinolone/tretinoin/h-quin TOPICAL CR

Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind NR
DESI2 Drug Ind -
Drug Category -
Drug Category S
Drug Type Code 1
Drug Type Code S
FDA Approval Date 03/11/2002
FDA Approval Date 01/18/2002
FDA Therap Equiv GM
FDA Therap Equiv NR
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date 03/11/2002
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date -
Unit GM
Unit 30
Units Per Pkg 01/18/2002
Units Per Pkg 30
Active Ingredients 1954 tretinoin 302794; 2019 hydroquinone 123319; 2193 fluocinolone acetonide 67732
Active Ingredients 1954 tretinoin 302794; 2019 hydroquinone 123319; 2193 fluocinolone acetonide 67732
AHFS Class 84500400 DEPIGMENTING AGENTS
AHFS Class 84500400 DEPIGMENTING AGENTS
DEA Class NC
DEA Class NC
Dose Form CREAM (GRAM)
Dose Form CREAM (GRAM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 49965 fluocinolone/tretinoin/h-quin TOPICAL CREAM (G) 0.01-.05-4
Gen Code and Des 49965 fluocinolone/tretinoin/h-quin TOPICAL CREAM (G) 0.01-.05-4
Inactive Ingredients 2332 sodium citrate 68042; 3203 paraben 99967; 6300 sulfite 14265453; 6364 magnesium aluminum silicate 1327431
Inactive Ingredients 2332 sodium citrate 68042; 3203 paraben 99967; 6300 sulfite 14265453; 6364 magnesium aluminum silicate 1327431
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength -
Strength -
Common Brand Name COMMON BRAND NAME(S): Tri-Luma
Common Brand Name COMMON BRAND NAME(S): Tri-Luma
Drug Interaction DRUG INTERACTIONS: 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. Some products that may interact with this drug are: other medicated skin products (such as soaps, cleansers, skin medications, skin-drying cosmetics), hormone-based birth control products (such as birth control pills, hormone implants).
Drug Interaction DRUG INTERACTIONS: 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. Some products that may interact with this drug are: other medicated skin products (such as soaps, cleansers, skin medications, skin-drying cosmetics), hormone-based birth control products (such as birth control pills, hormone implants).
Allocation Period -
Allocation Period -
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 30
Drug Form Pack Size 30
Form CREAM
Form CREAM
Hazard Code -
Hazard Code -
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
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 30 Refrige./DoNot Freez
Temp Zone 30 Refrige./DoNot Freez
Unit EA
Unit EA
Unit Size 30
Unit Size 30
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Before using, apply a small amount of this medicine to an area of unbroken skin, and check the area within 24 hours for any serious side effects. If the test area is itching, red, puffy, or blistering, do not use this product and contact your doctor. If there is just mild redness, then treatment with this product may begin. Before using, gently wash your face and neck with a mild soapless cleanser. Rinse and pat dry the skin. Apply a thin layer of medication to the affected area, including about 1/2 inch (1.5 centimeters) of normal-appearing skin around the affected area as directed by your doctor, usually once daily 30 minutes before bedtime. Rub the medication into the skin gently and completely. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. This medication may make the treated areas of skin more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen of SPF 30 or greater and wear protective clothing on the treated areas of skin when outdoors, even on cloudy or hazy days. If you experience dry skin from using this product, you may use a skin moisturizer in the morning after washing your face. You may also use a moisturizer and cosmetics during the day while using this medication. Avoid getting this product in your eyes or on the inside of your nose or mouth. If you do get this medication in those areas, flush with plenty of water. If severe irritation occurs, seek medical attention promptly. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each night. It may take up to 4 weeks to notice significant improvement. However, this medication is not recommended for long-term use (such as longer than 8 weeks) without stopping the medication for short periods. Tell your doctor if your condition lasts or gets worse after 4 weeks of treatment.
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Before using, apply a small amount of this medicine to an area of unbroken skin, and check the area within 24 hours for any serious side effects. If the test area is itching, red, puffy, or blistering, do not use this product and contact your doctor. If there is just mild redness, then treatment with this product may begin. Before using, gently wash your face and neck with a mild soapless cleanser. Rinse and pat dry the skin. Apply a thin layer of medication to the affected area, including about 1/2 inch (1.5 centimeters) of normal-appearing skin around the affected area as directed by your doctor, usually once daily 30 minutes before bedtime. Rub the medication into the skin gently and completely. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. This medication may make the treated areas of skin more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen of SPF 30 or greater and wear protective clothing on the treated areas of skin when outdoors, even on cloudy or hazy days. If you experience dry skin from using this product, you may use a skin moisturizer in the morning after washing your face. You may also use a moisturizer and cosmetics during the day while using this medication. Avoid getting this product in your eyes or on the inside of your nose or mouth. If you do get this medication in those areas, flush with plenty of water. If severe irritation occurs, seek medical attention promptly. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each night. It may take up to 4 weeks to notice significant improvement. However, this medication is not recommended for long-term use (such as longer than 8 weeks) without stopping the medication for short periods. Tell your doctor if your condition lasts or gets worse after 4 weeks of treatment.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another skin problem unless told to do so by your doctor. A different medication may be necessary in that case. Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another skin problem unless told to do so by your doctor. A different medication may be necessary in that case. Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details.
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 (FLOO-oh-SIN-oh-lone/tret-ih-NO-in/hi-dro-KWIN-own)
Phonetic Pronunciation (FLOO-oh-SIN-oh-lone/tret-ih-NO-in/hi-dro-KWIN-own)
Precautions PRECAUTIONS: Before using fluocinolone/tretinoin/hydroquinone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone, prednisone); 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 sulfites), 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: asthma, open sores or broken areas of skin (especially on the face or hands), other skin conditions (such as eczema, psoriasis). Too much bleaching of the skin might occur in some cases, resulting in an undesirable cosmetic effect in those with darker skin. Consult your doctor or pharmacist for more details. Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked. 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 these drugs pass into breast milk when applied to the skin. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before using fluocinolone/tretinoin/hydroquinone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone, prednisone); 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 sulfites), 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: asthma, open sores or broken areas of skin (especially on the face or hands), other skin conditions (such as eczema, psoriasis). Too much bleaching of the skin might occur in some cases, resulting in an undesirable cosmetic effect in those with darker skin. Consult your doctor or pharmacist for more details. Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked. 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 these drugs pass into breast milk when applied to the skin. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also How to Use. Mild burning, stinging, redness, dryness, or acne may occur. 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, skin cracking/shedding, "spider veins" (telangiectasia), stretch marks, other skin discoloration (besides melasma), small red bumps on the skin (folliculitis), blue-black darkening of the skin, numbness/tingling of hands/feet, increased pain/touch sensitivity. Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. 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 any 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: See also How to Use. Mild burning, stinging, redness, dryness, or acne may occur. 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, skin cracking/shedding, "spider veins" (telangiectasia), stretch marks, other skin discoloration (besides melasma), small red bumps on the skin (folliculitis), blue-black darkening of the skin, numbness/tingling of hands/feet, increased pain/touch sensitivity. Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. 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 any 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 in the refrigerator. Do not freeze. 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 in the refrigerator. Do not freeze. 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 combination medication is used to treat melasma on the face. Melasma is a condition of dark patchy areas on the skin, especially on the cheeks and forehead. It sometimes occurs with hormone changes. This product contains 3 different kinds of medication. Hydroquinone is a reversible skin bleaching agent. Tretinoin is a retinoid that increases skin shedding. Fluocinolone is a medium strength corticosteroid that reduces swelling, itching, and redness. This medication may improve your melasma, but it is not a cure. Continued exposure to some of the causes of melasma (such as sunlight, estrogen-type birth control hormones) may cause it to return.
Uses USES: This combination medication is used to treat melasma on the face. Melasma is a condition of dark patchy areas on the skin, especially on the cheeks and forehead. It sometimes occurs with hormone changes. This product contains 3 different kinds of medication. Hydroquinone is a reversible skin bleaching agent. Tretinoin is a retinoid that increases skin shedding. Fluocinolone is a medium strength corticosteroid that reduces swelling, itching, and redness. This medication may improve your melasma, but it is not a cure. Continued exposure to some of the causes of melasma (such as sunlight, estrogen-type birth control hormones) may cause it to return.

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The cost of TRI-LUMA CRM 30 GM is $ 423.16.
TRI-LUMA CRM 30 GM is manufactured by Galderma.
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