Adapalene Gel 0.1%

Manufacturer
MOHNARK PHARMACEUTICALS INC
Effective date
2025-07-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:11

Label at a glance#

ProductAdapalene Gel 0.1%
Active ingredientADAPALENE
Label structure15 sections

Indications and uses

For the treatment of acne

Dosage and administration

Adults and children 2 years 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 is 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 results or better results, but may worsen skin irritation. Children under 12 years ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Adapalene (retinoid) 0.1%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Carbopol 980, edetate disodium, benzyl alcohol, Poloxamer 124, Propylene Glycol, Purified Water, Sodium Hydroxide

PURPOSE

OTC - PURPOSE SECTION

Acne Treatment

WARNINGS

WARNINGS SECTION

For external use only

USES

INSTRUCTIONS FOR USE SECTION

For the treatment of acne

DO NOT USE

OTC - DO NOT USE SECTION

  • on damaged skin (cuts, abrasions, eczema, sunburn)
  • If you are allergic to adapalene or any of the ingredients in this product

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • 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 irritation that becomes severe
  • irritation (redness, itching, dryness, burning) is more likely to occur
  • in the first few weeks of use
  • if using more 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 results
  • avoid product contact with eyes, lips and mouth. if contact occurs, immediately flush area with water
  • wash hands after use

STOP USE AND ASK A DOCTOR IF

OTC - ASK DOCTOR SECTION

  • you become pregnant, or are 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 becomes severe
  • you see no improvement after 3 months of once daily use

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

Adults and children 2 years 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 is 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 results or better results, but may worsen skin irritation.

Children under 12 years of age ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Store at USP controlled room temperature 20 - 25 0 C (68 - 77 0F)
  • protect from freezing

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Adapalene is a topical retinoid used for treating acne vulgaris

RECENT MAJOR CHANGES SECTION

Added description for indications and usage

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply a thin film of Adapalene Gel, 0.1% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.

For topical use only. Not for ophthalmic, oral or intravaginal use.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label - NDC 73715-003-01

Adapalene Gel, 0.1%

For external use only

Once daily Topical Acne Treatment

Net Wt 1 oz (30 grams)

Adapalene cartonAdapalene carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307731adapalene 0.1 % Topical GelPSN2
307731adapalene 0.001 MG/MG Topical GelSCD2
307731adapalene 0.1 % Topical GelSY2

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73715-003-01Adapalene Gel 0.1%30 g in 1 TUBEGEL302

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
73715-00373715-003-01

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
38e372b4-1962-e6ac-e063-6294a90af1c922824b46-53a1-6b19-e063-6394a90a18ad2025-07-01WarningsExact identifier
spl id: 38e372b4-1962-e6ac-e063-6294a90af1c9
spl set id: 22824b46-53a1-6b19-e063-6394a90a18ad

Reported adverse events (FAERS/openFDA)#

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