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Adapalene Gel Tube 0.3% 45Gm-Teva

  • Manufacturer Name : ACTAVIS PHARMA
  • MFG # : 00472-0126-45
  • NDC : 00472012645
  • Distributor Name : AmeriSource Bergen
  • UPC : 304720126454
  • GTIN : 30304720126455
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Product Properties:

Description N
Description -
DESI Drug Ind $3.41; 07/01/2017
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Category 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. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.
Drug Type Code 1
Drug Type Code COMMON BRAND NAME(S): Differin
FDA Approval Date 10/27/2014
FDA Therap Equiv AB
HCPCS 1
HCPCS -
Market Entry Date 11/03/2014
Medical Coverage -
Medical Coverage -
Termination Date (a-DAP-a-leen)
Termination Date -
Unit GM
Units Per Pkg 45
Active Ingredients 5905 adapalene 106685409
Active Ingredients 5905 adapalene 106685409
AHFS Class 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
AHFS Class 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
DEA Class NC
DEA Class NC
Dose Form GEL (GRAM)
Dose Form GEL (GRAM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 62811 adapalene TOPICAL GEL (GRAM) 0.3 %
Gen Code and Des 62811 adapalene TOPICAL GEL (GRAM) 0.3 %
Inactive Ingredients 2468 propylene glycol 57556; 3203 paraben 99967; 3785 edetic acid 60004
Inactive Ingredients 2468 propylene glycol 57556; 3203 paraben 99967; 3785 edetic acid 60004
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 0.3%
Strength 0.3%
Common Brand Name COMMON BRAND NAME(S): Differin
Common Brand Name -
Drug Interaction -
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. 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, salicylic acid. If you have recently used products containing sulfur, resorcinol or salicylic acid, use adapalene with caution. Wait until the effects of such products on the skin have decreased before using adapalene.
Allocation Period -
Allocation Period -
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 45
Drug Form Pack Size 45
Form GELATIN
Form GELATIN
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
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 20 Cool-Store Cont Temp
Temp Zone 20 Cool-Store Cont Temp
Unit EA
Unit EA
Unit Size 45
Unit Size 45
How to Use HOW TO USE: If you are using the over-the-counter product to self-treat, read and follow all directions on the product package before using this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, use it as directed. Use this medication as directed by your doctor or the product package, usually once daily at bedtime. Before using, gently clean the affected skin with a mild or soapless cleanser and pat dry. If you are using the gel, cream, or lotion, wash your hands before and after applying this medication. Use your fingertips to apply a small amount of medication in a thin layer. If you are using the medicated swab, unwrap the swab and apply a thin layer to the affected area(s). Use this medication on the skin only. Avoid getting this medication in your eyes or on your lips. Do not apply to the inner lip area or inside the nose/mouth. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Do not apply to cut, scraped, or sunburned areas, or to skin affected by eczema (a skin condition). During the first few weeks of using adapalene, your acne might appear worse because the medication is working on pimples forming inside the skin. It may take 8 to 12 weeks to notice results from this medication. Use this medication regularly 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 often than directed. Your skin will not improve any faster, and your risk of developing side effects (such as redness, peeling, or pain) will increase. This medication is available in different strengths and forms (such as gel, cream, lotion). The best type of medication for you to use will depend on the condition of your skin and your response to treatment. Tell your doctor if your condition does not get better or if it gets worse. Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.
How to Use -
Missed Dose 45
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 GM
Overdose AB
Overdose OVERDOSE: 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. This medication may be harmful if swallowed.
Phonetic Pronunciation (a-DAP-a-leen)
Phonetic Pronunciation -
Precautions PRECAUTIONS: Before using adapalene, 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, 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 adapalene. Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product. Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication. Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using adapalene. Adapalene may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions -
Side Effects -
Side Effects SIDE EFFECTS: A brief sensation of 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 2-4 weeks of using the medication. These effects usually decrease with continued use. If any of these effects lasts or gets worse, tell your doctor or pharmacist promptly. Your doctor may want you to decrease how often you use adapalene, change the strength, or have you stop using it. If your doctor has directed you to use this medication, remember that 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: very red/irritated skin, an intense burning sensation, eye redness and watering (conjunctivitis), eyelid swelling, 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. Avoid freezing. Different forms of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. 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 10/27/2014
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. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.
Uses -

Frequently Asked Questions(FAQs)

The cost of Adapalene Gel Tube 0.3% 45Gm-Teva is available for registerd members only .
Adapalene Gel Tube 0.3% 45Gm-Teva is manufactured by ACTAVIS PHARMA .
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