• 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. Adults and children 12 years of age and older: 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 ...
Adapalene USP 0.1% (retinoid)*
*read consumer information leaflet
.Acne treatment
for the treatment of acne
For external use only
on damaged skin (cuts, abrasions, eczema, sunburn) if you are allergic to adapalene or any of the ingredients in this product
If pregnant or breast-feeding, ask a doctor before use
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
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
If swallowed, get medical help or contact a Poison Control Center right away
• 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. Adults and children 12 years of age and older:
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
store at room temperature 68º to 77ºF protect from freezing
carbomer homopolymer, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water and sodium hydroxide
1-800-768-2913
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850004234563 | GTIN-13: 0850004234563 EAN-13: 0850004234563 GTIN-12: 850004234563 UPC-A: 850004234563 GTIN storage (14 digits): 00850004234563 | 2H23AdapaleneGelParabenFree15gCartonv7_2.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a46239a7-5963-4008-8cbb-6b9000f497eb | Product name | 1 | 20250721 |
| d9d61457-6a5a-41fc-b418-e5479a2904b7 | Product name | 2 | 20230303 |
| 91d0a1ed-5d14-5017-c7aa-3602ee038695 | Product name | 3 | 20210111 |
| 3f45980c-c196-47e5-0e5e-48b7c57327c5 | Product name | 5 | 20200428 |
| 5c3dfd42-8936-4261-a420-cfcbbf3030aa | Product name | 2 | 20161206 |
| 08f39758-2d46-8afe-73ca-39fe69052a2b | Product name | 1 | 20140508 |
| 8ae7bcde-1dd2-b073-852b-f464987f7427 | Product name | 1 | 20140508 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 80861-114 | 80861-114-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ADAPALENE | 1L4806J2QF | ACTIB |
| CARBOMER HOMOPOLYMER TYPE C | 4Q93RCW27E | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-07-24 | full-release | 2026-06-01 01:08:30 |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091314-001 | ADAPALENE | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | AB | 2010-07-01 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091314-002 | ADAPALENE | 0.1% | GEL / TOPICAL | 2019-07-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | AB | 2010-07-01 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | A091314-002 | ADAPALENE | 0.1% | GEL / TOPICAL | 2019-07-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | AB | 2010-07-01 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | A091314-002 | ADAPALENE | 0.1% | GEL / TOPICAL | 2019-07-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | AB | 2010-07-01 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091314-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-07-01 | 053a50430f4f… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A091314-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A091314-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091314-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091314-001 | AB | 1 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Adapalene Gel | ADAPLAENE | Acne Free LLC | 0ce4684a-4733-e669-e063-6394a90a58c1 | 2026-07-31 | Warnings | 80861-114-01 80861-114 80861011401 57f499d2-c644-4c58-e063-6394a90a9baf 0ce4684a-4733-e669-e063-6394a90a58c1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.