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Adapalene-Benz Per 0.1%-2.5% Gel 45 Gm

  • Manufacturer Name : Glenmark Generics
  • MFG # : 68462030147
  • NDC : 68462030147
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
293076 UN
$24.57
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adapalene/benzoyl peroxide TOPICAL GEL W

Product Properties:

Description N
Description -
DESI Drug Ind -; -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Category USES: This medication is used on the skin to treat acne. This medication is a combination of adapalene (a retinoid) and benzoyl peroxide (an antibiotic and skin-peeling agent). This product may decrease the number and severity of acne pimples and promote quick healing of pimples that do appear. Adapalene works by affecting the growth of cells and decreasing swelling and inflammation. Benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel off..
Drug Type Code 1
Drug Type Code COMMON BRAND NAME(S): Epiduo
FDA Approval Date 11/08/2019
FDA Therap Equiv AB
HCPCS 1
HCPCS -
Market Entry Date 12/24/2019
Medical Coverage -
Medical Coverage -
Termination Date (a-DAP-a-leen/BEN-zoh-il per-OX-ide)
Termination Date -
Unit GM
Units Per Pkg 45
Active Ingredients 1955 benzoyl peroxide 94360; 5905 adapalene 106685409
Active Ingredients 1955 benzoyl peroxide 94360; 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 WITH PUMP (GRAM)
Dose Form GEL WITH PUMP (GRAM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 68880 adapalene/benzoyl peroxide TOPICAL GEL W/PUMP 0.1 %-2.5%
Gen Code and Des 68880 adapalene/benzoyl peroxide TOPICAL GEL W/PUMP 0.1 %-2.5%
Inactive Ingredients 2468 propylene glycol 57556; 3785 edetic acid 60004; 7543 sorbitan esters
Inactive Ingredients 2468 propylene glycol 57556; 3785 edetic acid 60004; 7543 sorbitan esters
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 0.1%-2.5%
Strength 0.1%-2.5%
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Epiduo
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 include: other acne skin treatments (such as tretinoin, dapsone). 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 this product with caution. Wait until the effects of such products on the skin have decreased before using this product.
Drug Interaction -
Allocation Period -
Allocation Period -
Case Quantity 96
Case Quantity 96
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 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 45
Unit Size 45
How to Use HOW TO USE: Wash your hands before applying this medication. Gently clean the affected skin with a mild or soapless cleanser and pat dry. Apply a thin layer of this medication usually once daily or as directed by your doctor. Use your fingertips to apply a small amount of medication (about the size of a pea) to the affected areas of skin. Use this medication on the skin only. Do not apply to the inner lip area, inside the nose/mouth, or on mucous membranes. 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. Your dosage and treatment plan is based on your medical condition and response to treatment. During the first few weeks of using adapalene, your acne might appear worse because the medication is working on pimples forming inside the skin. 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 recommended. Your skin will not improve any faster, and it will increase the risk of developing redness, peeling, and pain. Tell your doctor if your condition does not improve or if it worsens. 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 miss a dose, apply 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 GM
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 AB
Phonetic Pronunciation -
Phonetic Pronunciation (a-DAP-a-leen/BEN-zoh-il per-OX-ide)
Precautions PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to adapalene or benzoyl peroxide; 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: other skin conditions (such as eczema). This drug may bleach hair or colored fabric (such as clothing, bedding, and towels). Use caution when applying near the hairline, while dressing, and while choosing towel and bed sheet colors (if leaving on the skin overnight). This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen 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 this product. Weather extremes such as wind or cold may also be irritating to the skin. 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 this medication. 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 when used on the skin. Consult your doctor before breast-feeding.
Precautions -
Side Effects -
Side Effects SIDE EFFECTS: Skin redness, dryness, peeling, mild burning, swelling, or worsening of acne may occur during the first 4 weeks of using this product. These effects usually decrease with continued use. If any of these effects last or get worse, notify your doctor or pharmacist promptly. Your doctor may want you to use a moisturizer, decrease how often you use the product, or have you stop using it. 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. 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. 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 11/08/2019
Uses -
Uses USES: This medication is used on the skin to treat acne. This medication is a combination of adapalene (a retinoid) and benzoyl peroxide (an antibiotic and skin-peeling agent). This product may decrease the number and severity of acne pimples and promote quick healing of pimples that do appear. Adapalene works by affecting the growth of cells and decreasing swelling and inflammation. Benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel off..

Frequently Asked Questions(FAQs)

The cost of ADAPALENE-BENZ PER 0.1%-2.5% GEL 45 GM is $ 24.57.
ADAPALENE-BENZ PER 0.1%-2.5% GEL 45 GM is manufactured by Glenmark Generics.
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