ADAPALENE Gel

Manufacturer
Menodi Pharmaceuticals Co., Limited | Avily Pharmaceutical Co., Ltd.
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:34:26

Label at a glance#

ProductADAPALENE Gel
Active ingredientADAPALENE
Label structure13 sections

Storage and handling

store at room temperature 68°F to 77°F protect from freezing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ADAPALENE GEL

OTC - ACTIVE INGREDIENT SECTION

ADAPALENE 0.1%

OTC - PURPOSE SECTION

Acne treatment

INDICATIONS & USAGE SECTION

Usefor the treatment of acne

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

on damaged skin (cuts,abrasions, eczema, sunburn)

if you are allergic to adapalene or any oftheingredients in this product

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

If swallowed, get medical help or contact a PoisonControl Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

store at room temperature 68°F to 77°F
protect from freezing

INACTIVE INGREDIENT SECTION

Carbomer
Poloxamer
Disodium EDTA
Metabisulfite
Phenoxyethanol
Propylene Glycol
Sodium Hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307731adapalene 0.1 % Topical GelPSN1
307731adapalene 0.001 MG/MG Topical GelSCD1
307731adapalene 0.1 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADAPALENE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84893-001-01ADAPALENE Gel15 g in 1 BOTTLEGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84893-001ADAPALENE GEL (ADAPALENE) GEL [MENODI PHARMACEUTICALS CO., LIMITED]11 package rows20241107_263b9cb0-b749-ca20-e063-6394a90a0d2f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84893-00184893-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
263b9cb0-b74a-ca20-e063-6394a90a0d2f263b9cb0-b749-ca20-e063-6394a90a0d2f2024-11-06WarningsExact identifier
spl id: 263b9cb0-b74a-ca20-e063-6394a90a0d2f
spl set id: 263b9cb0-b749-ca20-e063-6394a90a0d2f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.