FDA Label for Adapalene
View Indications, Usage & Precautions
Adapalene Product Label
The following document was submitted to the FDA by the labeler of this product Glenmark Therapeutics Inc., Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Adapalene, USP 0.1% (retinoid)*
*read consumer Information leaflet
Purpose
Acne treatment
Use
▪ For the treatment of acne
Warnings
For external use only
Do not use
• 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 get irritation that becomes severe• irritation (redness, itching, dryness, burning) is more likely to occur:• in the first few weeks of use• if using 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 the area with water.• wash hands after use• you become pregnant, or are planning to become pregnant, while using the 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 pregnant or breastfeeding, ask a doctor before use
When using this product
Stop use and ask doctor if
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Adults and children 12 years of age 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 or better results, but may worsen skin irritation.• Children under 12 years of age: ask a doctor
Other Information
• store at room temperature 68°F to 77°F• protect from freezing
Inactive Ingredients
carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide
Questions Or Comments?
1 (888) 721-7115
Patient Leaflet
ADAPALENE GEL USP, 0.1%
ACNE TREATMENT
Frequently Asked Questions
What is adapalene gel 0.1% and what is it used for?
• Adapalene gel 0.1% is a topical retinoid medication used for the treatment of acne in people age 12 years and older.• Use only one time a day.• If pregnant or breastfeeding, ask a doctor before use.• Some other retinoid drugs have been shown to cause birth defects. There is no specific evidence that adapalene gel 0.1% causes birth defects in humans when used topically as directed.• Apply this product only one time a day and try to apply the product at the same time each day.• Gently clean the affected areas using a mild (non-irritating) cleanser and pat dry.• Apply adapalene gel 0.1% as a thin layer to the affected areas of the skin only one time a day. For example, if you get acne on the face, clean, dry and apply the product to the entire face. Adapalene gel 0.1% is not a spot treatment and should not be used to treat a single pimple.• It may take up to 3 months of daily use for results to appear.• Do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.• When possible, limit sun exposure, including light from tanning beds.• When going outdoors, use a sunscreen as labeled. Your skin may be more sensitive while using adapalene gel 0.1%. If you use this product during the day, allow it to dry before applying sunscreen.• Yes, use of a moisturizer may help decrease dryness and other signs of irritation. Avoid products containing alpha hydroxy or glycolic acids which may worsen irritation.• Irritation (redness, itching, dryness, burning) is more likely to occur:• In the first few weeks of use.• If irritation becomes severe (overly bothersome), stop use and ask a doctor before using the product again.• Do not use wax to remove hair in areas where the product has been applied because it may worsen skin irritation.• Adapalene gel 0.1% contains:• Adapalene gel 0.1% should be stored at room temperature [68° to 77°F]. Protect from freezing.• Do not use the product after the expiry date marked on the crimp of the tube.
What should I know before using the product?
How often do I apply the product?
How do I apply the product?
How long will it take for adapalene gel 0.1% to work?
What do I do if I need to be in the sun?
Can I use a moisturizer if my skin is dry?
When is my skin most likely to become irritated? And what do I do?
What do I do if my skin becomes severely irritated?
Can I remove unwanted facial hair by waxing while using this product?
What ingredients are used in adapalene gel 0.1%?
The active ingredient is adapalene 0.1%. The other ingredients are: carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide.
How should I store this product?
Other Questions? Where can I get more information?
Phone: 1 (888) 721-7115
February 2022
Package/Label Principal Display Panel
NDC 72657-102-17
Adapalene Gel USP, 0.1%
NET WT. 0.5 OZ (15 g)
NDC 72657-102-55
Adapalene Gel USP, 0.1%
NET WT. 1.6 OZ (45 g)
* Please review the disclaimer below.