Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

For topical use only; Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is not for oral, ophthalmic, or intravaginal use. Apply a thin film of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes.

Each gram of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque, aqueous based gel.

None

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

No formal drug-drug interaction studies were conducted with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%.

Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula:

Adapalene:

Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula:

Benzoyl Peroxide:

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.

The safety and efficacy of adapalene and benzoyl peroxide gel, 0.1%/2.5% applied once daily for the treatment of acne vulgaris were assessed in two 12-week, multicenter, controlled clinical studies of similar design, comparing adapalene and benzoyl peroxide gel, 0.1%/2.5% to the gel vehicle in acne subjects. Treatment response was defined as the percent of subjects who had a two grade improvement and rated ‘Clear’ and ‘Almost Clear’ at Week 12 based on the Investigator’s Global Assessment (IGA) and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts.

An IGA score of ‘Clear’ corresponded to residual hyperpigmentation and erythema may be present. An IGA score of ‘Almost Clear’ corresponded to a few scattered comedones and a few small papules.

In Study 1, 517 subjects were randomized to adapalene and benzoyl peroxide gel, 0.1%/2.5%, adapalene 0.1% in vehicle gel, benzoyl peroxide 2.5% in vehicle gel, or vehicle gel. The median age of these 517 subjects was 15 years old and 60% were males.

At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. The majority of subjects had a baseline IGA score of ‘Moderate’ which corresponded to more than half of the face is involved, many comedones, papules and pustules. The efficacy results at week 12 are presented in Table 3.

In Study 2, 1668 subjects were randomized to adapalene and benzoyl peroxide gel, 0.1%/2.5%, adapalene 0.1% in vehicle gel, benzoyl peroxide 2.5% in vehicle gel, or vehicle gel. The median age of subjects was 16 years old and 49% were males. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions as well as an Investigator Global Assessment score of ‘Moderate’. The efficacy results at week 12 are presented in Table 3.

In Study 3, 285 pediatric subjects 9 to 11 years of age were randomized to adapalene and benzoyl peroxide gel, 0.1%/2.5% or vehicle gel. The median age of subjects was 11 years and 24% were males. At baseline, subjects had a minimum of 20 but not more than 100 total lesions (inflammatory and/or non-inflammatory) with an Investigator Global Assessment score of ‘Moderate’. The efficacy results at week 12 are presented in Table 3.

Table 3: Clinical Efficacy of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% at Week 12

In both Studies 1 and 2 the treatment effect was smaller in subjects with a small number of baseline lesions than in subjects with a large number of baseline lesions.

* - That is, a mean percent increase of 13.2%

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows:

 

45 gram tube NDC 45802-846-84

 

45 gram pump NDC 45802-846-01

Storage and handling

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Store at 25°C; excursions permitted to 15° – 30°C (59° – 86°F).

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Protect from light.

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Keep out of reach of children.

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Keep away from heat.

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Keep tube tightly closed.

[See FDA Approved Patient Labeling (Patient Information)]

Information for Patients

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Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% as a thin layer, avoiding the eyes, lips and mucous membranes.

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Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation.

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Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% may cause irritation such as erythema, scaling, dryness, stinging or burning.

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Advise patients to minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel, (e.g., hat) when exposure cannot be avoided.

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Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% may bleach hair and colored fabric.

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%

Important: For use on the skin only (topical). Do not use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in or on your mouth, eyes, or vagina.

Read this Patient Information leaflet about Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, talk with your doctor or pharmacist.

What is Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age and older.

Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

It is not known if Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is safe and effective in children younger than 9 years old.

What should I tell my doctor before using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?

Before you use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, tell your doctor if you:

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have other skin problems, including cuts or sunburn

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have any other medical conditions

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are pregnant or planning to become pregnant. It is not known if Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

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are breastfeeding or plan to breastfeed. It is not known if Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Especially tell your doctor if you use any other medicine for acne. Using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?

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Use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% exactly as your doctor tells you to use it. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is for skin use only. Do not use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in or on your mouth, eyes, or vagina.

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Apply Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 time a day.

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Do not use more Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% than you need to cover the treatment area. Using too much Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% or using it more than 1 time a day may increase your chance of skin irritation.

Applying Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%:

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Wash the area where the gel will be applied with a mild cleanser and pat dry.

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Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% comes in a tube and a pump.

If you have been prescribed the:

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Tube: Squeeze a small amount (about the size of a pea) of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% onto your fingertips and spread a thin layer over the affected area.

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Pump: Depress the pump to dispense a small amount (about the size of a pea) of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% and spread a thin layer over the affected area.

What should I avoid while using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?

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You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should wear sunscreen and wear a hat and clothes that cover the areas treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% if you have to be in sunlight.

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You should avoid weather extremes such as wind and cold as this may cause irritation to your skin.

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You should avoid applying Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% to cuts, abrasions and sunburned skin.

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You should avoid skin products that may dry or irritate your skin such as harsh soaps, astringents, cosmetics that have strong skin drying effects and products containing high levels of alcohol.

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You should avoid the use of “waxing” as a hair removal method on skin treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

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Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% may bleach your clothes or hair. Allow Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% to dry completely before dressing to prevent bleaching of your clothes.

What are the possible side effects of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% may cause serious side effects including:

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Local skin reactions. Local skin reactions are most likely to happen during the first 4 weeks of treatment and usually lessen with continued use of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Signs and symptoms of local skin reaction include:

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Redness

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Dryness

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Swelling

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Scaling

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Stinging or burning

Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse, you may have to stop using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Padagis at 1-866-634-9120.

How should I store Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?

 

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Store Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% at room temperature, 68° – 77° F (20° – 25° C)

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Keep Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% inside container and out of light and away from heat.

Keep Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% and all medicines out of the reach of children.

General information about Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% for a condition for which it was not prescribed. Do not give Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% that is written for health professionals.

What are the ingredients in Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?

Active ingredient: adapalene and benzoyl peroxide

Inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan oleate.

Manufactured by Padagis®

Yeruham, Israel

www.padagis.com

Rev 02-23

7T2W8 RC F4

NDC 45802-846-01

Rx Only

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%

Pump

For Topical Use Only

NET WT 45 g