Acne Relief (Adapalene Gel 0.1%)

Manufacturer
Little Pharma, Inc.
Effective date
2026-01-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:52:11

Label at a glance#

ProductCurist Acne Relief
Active ingredientADAPALENE
Label structure11 sections

Storage and handling

Other information store at room temperature 68º to 77ºF protect from freezing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet

OTC - PURPOSE SECTION

Purpose

Acne treatment

INDICATIONS & USAGE SECTION

Use

for the treatment of acne

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use

OTC - WHEN USING SECTION

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 become 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 result
  • avoid product contact eyes, lips, and month. If contact occurs immediately flush the area with water.
  • wash hands after use

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

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 in 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

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 68º to 77ºF
  • protect from freezing

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions? Call 1 (888) 721-7115

SPL UNCLASSIFIED SECTION

*Read carton and enclosed consumer information leaflet before using this product. Keep this carton and consumer information leaflet.The contain important information.

Distributed by: Little Pharma, Inc.

New York, NY 10023 | Made in India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

curist

Acne Relief

Adapalene Gel, 0.1%

Acne Teatment

Once Daily Topical Retinoid*

Fragrance Free

Oil Free

NET WT 1.6 oz (45 g)

AdapaleneGel-45G FinalAdapaleneGel-45G Final

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307731adapalene 0.1 % Topical GelPSN3
307731adapalene 0.001 MG/MG Topical GelSCD3
307731adapalene 0.1 % Topical GelSY3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372559015133GTIN-13: 0372559015133
EAN-13: 0372559015133
GTIN-12: 372559015133
UPC-A: 372559015133
GTIN storage (14 digits): 00372559015133
AdapaleneGel-45G Final.jpg

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
72559-015-13Curist Acne Relief45 g in 1 TUBEGEL453
72559-015-13Curist Acne Relief1 in 1 CARTONGEL13
72559-015-17Curist Acne Relief2 in 1 PACKAGE, COMBINATIONGEL23
72559-015-17Curist Acne Relief1 in 1 CARTONGEL13

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
72559-01572559-015-13, 72559-015-17

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-06-21full-release2026-06-01 00:34:34

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
Curist Acne ReliefADAPALENELittle Pharma, Inc.e6380880-5299-0826-e053-2a95a90a19422026-01-11WarningsExact identifier
ndc (package): 72559-015-17
ndc (package): 72559-015-13
ndc (product): 72559-015
ndc11 (package): 72559001513
ndc11 (package): 72559001517
spl id: 4821e693-2293-b60e-e063-6294a90a7d86
spl set id: e6380880-5299-0826-e053-2a95a90a1942

Reported adverse events (FAERS/openFDA)#

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