Label: ADAPALENE gel
- NDC Code(s): 51672-2143-1, 51672-2143-6
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated January 13, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
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.
When using 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
Stop use and ask doctor if
- 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
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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Adapalene Gel USP, 0.1%
Frequently Asked Questions
What is adapalene gel and what is it used for?
- Adapalene gel is a topical retinoid medication used for the treatment of acne in people age 12 years and older.
- Use only one time a day.
What should I know before using the product?
- If pregnant or breast-feeding, 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.
- Do not use adapalene gel if you are allergic to adapalene or any of the ingredients in this product.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
How often do I apply the product?
- Apply this product only one time a day and try to apply the product at the same time each day.
How do I apply the product?
- Gently clean the affected areas using a mild (non-irritating) cleanser and pat dry.
- Apply adapalene gel 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 is not a spot treatment and should not be used to treat a single pimple.
- Avoid product contact with eyes, lips and mouth. If contact occurs, immediately flush the area with water.
- Do not apply product to damaged skin (cuts, abrasions, eczema, or sunburn).
- Wash hands after use.
How long will it take for adapalene gel to work?
- 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.
What do I do if I need to be in the sun?
- When possible, limit sun exposure, including light from tanning beds.
- When going outdoors, use sunscreen as labeled. Your skin may be more sensitive while using adapalene gel. If you use this product during the day, allow it to dry before applying sunscreen.
Can I use a moisturizer if my skin is dry?
- 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.
When is my skin most likely to become irritated? And what do I do?
- Irritation (redness, itching, dryness, burning) is more likely to occur:
- In the first few weeks of use.
- If using abrasive skin cleansers, products with drying effects or more than one topical acne medication at a time. You may want to delay starting adapalene gel until any irritation from using the other product(s) has gone away.
- Moisturizers may be used.
- Irritation usually lessens after 4 weeks of continued use.
What do I do if my skin becomes severely irritated?
- If irritation becomes severe (overly bothersome), stop use and ask a doctor before using the product again.
Can I remove unwanted facial hair by waxing while using this product?
- Do not use wax to remove hair in areas where the product has been applied because it may worsen skin irritation.
What ingredients are used in adapalene gel?
- Adapalene gel contains:
The active ingredient is adapalene USP, 0.1%. The other ingredients are: carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, sodium hydroxide.
How should I store this product?
- Adapalene gel 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 packaging.
Other Questions? Where can I get more information?
Mfd. by: Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1
Made in Canada
Issued: November 2021
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Adapalene (UNII: 1L4806J2QF) (Adapalene - UNII:1L4806J2QF) Adapalene 1 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) edetate disodium (UNII: 7FLD91C86K) methylparaben (UNII: A2I8C7HI9T) poloxamer 182 (UNII: JX0HIX6OAG) propylene glycol (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) sodium hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2143-1 1 in 1 CARTON 01/14/2022 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51672-2143-6 1 in 1 CARTON 01/14/2022 2 45 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215940 01/14/2022 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2143)