Adapalene

Manufacturer
GLENMARK THERAPEUTICS INC., USA | Glenmark Pharmaceuticals Limited
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:53:18

Label at a glance#

ProductAdapalene
Active ingredientADAPALENE
Label structure12 sections

Dosage and administration

• Adults and children 12 years of age 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 or better results, but may worsen skin irritation. • Children un...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Adapalene, USP 0.1% (retinoid)*

*read consumer Information leaflet

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

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

If pregnant or breastfeeding, ask a doctor before use

When using this product

  • 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 becomes severe
  • irritation (redness, itching, dryness, burning) is more likely to occur:
  • in the first few weeks of use
  • if using 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 the area with water.
  • wash hands after use

Stop use and ask doctor if

  • you become pregnant, or are planning to become pregnant, while using the 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

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age 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 or better results, but may worsen skin irritation.
  • Children under 12 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide

Questions or comments?

SPL UNCLASSIFIED SECTION

1 (888) 721-7115

Patient Leaflet

SPL UNCLASSIFIED SECTION

ADAPALENE GEL USP, 0.1%

ACNE TREATMENT

Frequently Asked Questions

What is adapalene gel 0.1% and what is it used for?

  • Adapalene gel 0.1% is a topical retinoid medication used for the treatment of acne in people age 12 years and older.
  • Use only one time a day.

What should I know before using the product?

  • If pregnant or breastfeeding, ask a doctor before use.
  • Some other retinoid drugs have been shown to cause birth defects. There is no specific evidence that adapalene gel 0.1% causes birth defects in humans when used topically as directed.

How often do I apply the product?

  • Apply this product only one time a day and try to apply the product at the same time each day.

How do I apply the product?

  • Gently clean the affected areas using a mild (non-irritating) cleanser and pat dry.
  • Apply adapalene gel 0.1% as a thin layer to the affected areas of the skin only one time a day. For example, if you get acne on the face, clean, dry and apply the product to the entire face. Adapalene gel 0.1% is not a spot treatment and should not be used to treat a single pimple.

How long will it take for adapalene gel 0.1% to work?

  • It may take up to 3 months of daily use for results to appear.
  • 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.

What do I do if I need to be in the sun?

  • When possible, limit sun exposure, including light from tanning beds.
  • When going outdoors, use a sunscreen as labeled. Your skin may be more sensitive while using adapalene gel 0.1%. If you use this product during the day, allow it to dry before applying sunscreen.

Can I use a moisturizer if my skin is dry?

  • Yes, use of a moisturizer may help decrease dryness and other signs of irritation. Avoid products containing alpha hydroxy or glycolic acids which may worsen irritation.

When is my skin most likely to become irritated? And what do I do?

  • Irritation (redness, itching, dryness, burning) is more likely to occur:
  • In the first few weeks of use.

What do I do if my skin becomes severely irritated?

  • If irritation becomes severe (overly bothersome), stop use and ask a doctor before using the product again.

Can I remove unwanted facial hair by waxing while using this product?

  • Do not use wax to remove hair in areas where the product has been applied because it may worsen skin irritation.

What ingredients are used in adapalene gel 0.1%?

  • Adapalene gel 0.1% contains:

The active ingredient is adapalene 0.1%. The other ingredients are: carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide.

How should I store this product?

  • Adapalene gel 0.1% should be stored at room temperature [68° to 77°F]. Protect from freezing.
  • Do not use the product after the expiry date marked on the crimp of the tube.

Other Questions? Where can I get more information?

Phone: 1 (888) 721-7115

February 2022

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72657-102-17

Adapalene Gel USP, 0.1%

NET WT. 0.5 OZ (15 g)

carton15mg
carton15mg

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72657-102-55

Adapalene Gel USP, 0.1%

NET WT. 1.6 OZ (45 g)

carton45gm
carton45gm

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

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72657-10272657-102-17, 72657-102-55

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

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091314-001ADAPALENEADAPALENE0.1%GEL / TOPICAL2010-07-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091314-001ADAPALENE0.1%GEL / TOPICALAB2010-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091314-002ADAPALENE0.1%GEL / TOPICAL2019-07-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091314-001ADAPALENE0.1%GEL / TOPICALAB2010-07-013f01610625f2…
2019-12-14 00:12 UTC2019-12A091314-002ADAPALENE0.1%GEL / TOPICAL2019-07-093f01610625f2…
2019-09-15 20:21 UTC2019-09A091314-001ADAPALENE0.1%GEL / TOPICALAB2010-07-01b00525d2431f…
2019-09-15 20:21 UTC2019-09A091314-002ADAPALENE0.1%GEL / TOPICAL2019-07-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A091314-001ADAPALENE0.1%GEL / TOPICALAB2010-07-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A091314-001ADAPALENE0.1%GEL / TOPICAL2010-07-01053a50430f4f…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A091314-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A091314-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091314-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091314-001AB1ea99ee380514…

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
14ae7a08-c9d1-44bd-8a5a-b07ef6ffc29e5d5340d6-e1da-46e4-973c-40cf8e907aa32026-03-26WarningsExact identifier
spl set id: 5d5340d6-e1da-46e4-973c-40cf8e907aa3

Reported adverse events (FAERS/openFDA)#

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