ADAPALENE GEL- adapalene gel

ADAPALENE Gel by

Drug Labeling and Warnings

ADAPALENE Gel by is a Otc medication manufactured, distributed, or labeled by Menodi Pharmaceuticals Co., Limited, Avily Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ADAPALENE GEL

ACTIVE INGREDIENT

ADAPALENE 0.1%

PURPOSE

Acne treatment

INDICATIONS & USAGE

Usefor 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 oftheingredients in this product

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

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADAPALENE GEL 
adapalene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84893-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER (UNII: 0A5MM307FC)
POLOXAMER 105 (UNII: XPP85ZHV76)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METABISULFITE ION (UNII: 7992SO049K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84893-001-01	15 g in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	11/06/2024

Labeler - Menodi Pharmaceuticals Co., Limited (989109246)

Establishment
Name	Address	ID/FEI	Business Operations
Avily Pharmaceutical Co., Ltd.		412484055	manufacture(84893-001)