Active Ingredient
Agapalene USP 0.1% (retinoid)*
*read consumer information leaflet
Adapalene Gel
FDA Label NDC 30142-725
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Adapalene (NDC 30142-725). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, pregnancy/breastfeeding,, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Pregnancy/Breastfeeding,
ask a doctor before use.
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 become 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 result
- avoid product contact eyes, lips, and month. If contact occurs immediately flush the area with water.
- wash hands after use
Stop Use And Ask A Doctor If
- you become pregnant, or 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 become severe
- you see no improvement after 3 months of once daily use
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 in 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 rooms temperature 68° to 77°F
- protect from freezing
Inactive Ingredients
carbomer homopolymer type C, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water
May contain hydrochloric acid and/orsodium hydroxide to adjust pH.
Questions Or Comments?
Call 1-800-632-6900
Principal Display Panel
Compare to the Active Ingredient in Differin® Gel†
Adapalene Gel USP 0.1%
acne treatment
ONCE DAILY TOPICAL RETINOID*
- Oil & fragrance free
- Dermatologist developed & tested
- previously available only by prescription
*READ CONSUMER INFORMATION LEAFLET BEFORE USE
*READ CARTON AND ENCLOSED CONSUMER INFORMATION LEAFLET BEFORE USING THIS PRODUCT.
KEEP THIS CARTON AND CONSUMER INFORMATION LEAFLET. THEY CONTAIN IMPORTANT INFORMATION.
†DIFFERIN® GEL IS A REGISTERED TRADEMARK OF GALDERMA LABORATORIES, L.P., DALLAS. TX7520, GALDERMA LABORATORIES, L.P. IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
Product Label
KROGER Acne Treatment
* Please review the disclaimer below.
