Active Ingredient
Adapalene USP 0.1% (retinoid)*
*read consumer information leaflet
The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Adapalene (NDC 73581-215). 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.
Adapalene USP 0.1% (retinoid)*
*read consumer information leaflet
Acne treatment
For the treatment of acne
For external use only
on damaged skin (cuts, abrasions eczema, sunburn)
if you are allergic to adapalene or any of the ingredients in this product
ask a doctor before use.
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:
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
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
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
store at rooms temperature 68° to 77°F
protect from freezing
carbomer homopolymer typeC, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
†Compare to the active ingredient in Differin® Gel
Adapalene Gel USP 0.1%
Acne Treatment
NET WT OZ (g)
*READ CONSUMER INFORMATION LEAFLET BEFORE USE.
*Read cartonand enclosed consumer information leaflet before using this product. Keep this carton and consumer information leaflet. They contain important information.
†This product is not manufactured or distributed by Galderma Laboratories, L.P. distributor of Differin® Gel.
DISTRIBUTED BY
Wellspring Meds
Airmont, NY 10952
* Please review the disclaimer below.