Other
ADAPALENE GEL
Adapalene Gel
FDA Label NDC 84893-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Menodi Pharmaceuticals Co., Limited for the product Adapalene Gel (NDC 84893-001). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
ADAPALENE 0.1%
Otc - Purpose
Acne treatment
Indications & Usage
Usefor the treatment of acne
Warnings
For external use only
Otc - Do Not Use
on damaged skin (cuts,abrasions, eczema, sunburn)
if you are allergic to adapalene or any oftheingredients in this product
Otc - When Using
limit sun exposure, including light from tanningbeds, and use sunscreen when goingoutdoors.
do not wax to remove hair in areas where theproduct has been applied.
during the early weeks of use, your acne mayappearto worsen before it improves (this is normal)continue using as directed, unless you get irritationthat becomes severe
irritation (redness, itching, dryness, burning) is morelikely to occur:
in the first few weeks of use.
if using more than one topical acne medication at atime
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. lfcontact occurs, immediatelyflush the area with waterwash hands after use
Otc - Stop Use
you become pregnant, or are planning to becomePregnant, while using the product.
you have symptoms of an allergic reaction (such asitching. rash, hives, swelling ofthe lips, eyelids, andshortness of breath.)
irritation becomes severe.
you see no improvement after3 months ofoncedaily use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a PoisonControl Center right away.
Dosage & Administration
Adults and children 12 years of age and older:
use once daily
clean the skin gently and pat dry before applyingthe product
cover the entire affected area with a thin layer. Forexample, if your acne is on the face, apply theproduct to the entire face.
do not use more than one time a day. Applyingmore than directed will not provide faster or betterresults, but may worsen skin irritation.Children under 12 years of age: ask a doctor
Storage And Handling
store at room temperature 68°F to 77°F
protect from freezing
Inactive Ingredient
Carbomer
Poloxamer
Disodium EDTA
Metabisulfite
Phenoxyethanol
Propylene Glycol
Sodium Hydroxide
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