Adapalene Gel 0.1% Gel
FDA Label NDC 73715-003

Adapalene (retinoid) 0.1%

Inactive ingredients:

Carbopol 980, edetate disodium, benzyl alcohol, Poloxamer 124, Propylene Glycol, Purified Water, Sodium Hydroxide

Acne Treatment

For external use only

For the treatment of acne

• on damaged skin (cuts, abrasions, eczema, sunburn)
• If you are allergic to adapalene or any of the ingredients in this product

• limit sun exposure, including light from tanning beds and use sunscreen when going outdoors
• do not wax to remove hair in areas where the product has been applied
• during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you irritation that becomes severe
• irritation (redness, itching, dryness, burning) is more likely to occur
• in the first few weeks of use
• if using more more than one topical acne medication at a time
• but irritation usually lessens with continued use of this product
• it may take up to 3 months of once daily use to see results
• avoid product contact with eyes, lips and mouth. if contact occurs, immediately flush area with water
• wash hands after use

• you become pregnant, or are planning to become pregnant, while using this product
• you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids and shortness of breath)
• irritation becomes severe
• you see no improvement after 3 months of once daily use

If swallowed, get medical help or contact a Poison Control Center right away

Adults and children 2 years and older:

• use once daily
• clean the skin gently and pat dry before applying the product
• cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face
• do not use more than one time a day. Applying more than directed will not provide faster results or better results, but may worsen skin irritation.

Children under 12 years of age ask a doctor

• Store at USP controlled room temperature 20 - 25 ⁰ C (68 - 77 ⁰F)
• protect from freezing

Adapalene is a topical retinoid used for treating acne vulgaris

Added description for indications and usage

Apply a thin film of Adapalene Gel, 0.1% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.

For topical use only. Not for ophthalmic, oral or intravaginal use.

Carton Label - NDC 73715-003-01

Adapalene Gel, 0.1%

For external use only

Once daily Topical Acne Treatment

Net Wt 1 oz (30 grams)

Adapalene Carton (Adapalenecarton)