FDA.reportPublic FDA data

Proactiv MD Kit

Manufacturer
Alchemee, LLC | kdc/one chatsworth, Inc. | Sun Pharma Canada Inc. | VEE PAK, LCC
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:56

Label at a glance#

ProductProactiv MD Kit
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 under 12 years...

Label contents#

Full prescribing information#

Adapalene Gel 0.1% - Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Adapalene Gel 0.1% - Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Adapalene Gel 0.1% (retinoid)

Adapalene Gel 0.1% - Purpose

OTC - PURPOSE SECTION

Acne treatment

Adapalene Gel 0.1% - Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Adapalene Gel 0.1% - Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

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

Adapalene Gel 0.1% - 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 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 a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe.

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.

Adapalene Gel 0.1% - 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.

Adapalene Gel 0.1% - 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

Adapalene Gel 0.1% - Other information

OTHER SAFETY INFORMATION

  • Store at room temperature 68o – 77oF
  • protect from freezing

Adapalene Gel 0.1% - Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, disodium EDTA, phenoxyethanol, poloxamer 182, propylene glycol, sodium hydroxide, water

Questions or comments?  

OTC - QUESTIONS SECTION

1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by Alchemee LLC
Santa Monica, CA 90401
Made in the USA of Foreign
and Domestic Components
Questions? 1-800-950-4695 • proactiv.com

Proactiv is a registered trademark
of Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - ProactivMD Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®

ProactivMD

3-step acne treatment system

Featuring our prescription-strength retinoid

Step 1: Cleanse

Washes away debris & oil

Step 2: Treat

First FDA-approved over-the-counter topical retinoid* for acne treatment
Previously available only by prescription.
Dermatologist developed and tested
*Read carton an consumer leaflet information before using
Step 3: Hydrate
Keeps skin hydrated & refreshed

Kit Contains: Ultra-Gentle Cleaner 2 FL. OZ. (60 mL) Adapalene Gel 0.1% 0.5 FL. OZ. (15 g) Ultra-Hydrating Moisturizer 1 FL. OZ. (30 mL)

image 1image 1

image 2image 2

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11410-224-302026-01-07C16284748780-13b156c62-3007-fb37-e063-e6dba90a4e07Proactiv MD Kit
11410-224-302025-07-29C16284748780-13b156c62-3007-fb37-e063-e6dba90a4e07Proactiv MD Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-224-30Proactiv MD Kit1 in 1 BOXKIT12
11410-958-15Proactiv MD Kit15 g in 1 TUBEGEL15 g in 1000.1 g in 100g2
11410-958-15Proactiv MD Kit1 in 1 BOXGEL0.1 g in 100g2

Products#

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

DailyMed product names page 1 of 2 · 63 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-22411410-224-30
11410-95811410-958-15

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 64 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XINGR
SODIUM CITRATE1Q73Q2JULRINGR
GLYCERINPDC6A3C0OXINGR
COCO-GLUCOSIDEICS790225BINGR
GREEN TEA LEAFW2ZU1RY8B0INGR
WATER059QF0KO0RINGR
DISODIUM COCOAMPHODIACETATE18L9G3U51MINGR
PANTHENOLWV9CM0O67ZINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
PHENOXYETHANOLHIE492ZZ3TINGR
SODIUM COCOAMPHOACETATEW7Q5E87674INGR
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 1.0%)8Z5ZAL5H3VINGR
SODIUM BENZOATEOJ245FE5EUINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
COCONUT ACID40U37V505DINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM HYDROXIDE55X04QC32IINGR
HELIOTROPINE BUTANE-2,3-DIOL ACETAL7Y4ZV19ZDPINGR
XANTHAN GUMTTV12P4NEEINGR
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKINGR
ISOPROPYL ALCOHOLND2M416302INGR
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
WATER059QF0KO0RIACT
ADAPALENE1L4806J2QFACTIB
EDETATE DISODIUM7FLD91C86KIACT
POLOXAMER 182JX0HIX6OAGIACT
ETHYLHEXYL PALMITATE2865993309INGR
HYDROGENATED POLYDECENE TYPE IU333RI6EB7INGR
LEVOMENOL24WE03BX2TINGR
GLYCOGEN309GSC92U1INGR
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36INGR
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINGR
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294INGR
PPG-2 MYRISTYL ETHER PROPIONATE88R97D8U8AINGR
MORUS ALBA ROOTCST1G9BZGDINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS8EPU9MJ01KINGR

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
A215940-001ADAPALENEADAPALENE0.1%GEL / TOPICAL2022-01-14

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-1484e616aacf4f…
2026-08-18 06:07:402026-07A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proactiv MD Adapalene Acne TreatmentADAPALENEAlchemee, LLC0a9b3755-c0db-4282-e063-6394a90a0c082026-01-07WarningsExact identifier
ndc (package): 11410-958-15
ndc (product): 11410-958
ndc11 (package): 11410095815
Proactiv MD KitMD KITAlchemee, LLC1d142dba-145c-fb33-e063-6394a90a88b62026-01-07WarningsExact identifier
ndc (package): 11410-224-30
ndc (package): 11410-958-15
ndc (product): 11410-224
ndc11 (package): 11410022430
ndc11 (package): 11410095815
spl id: 47d2a8aa-e405-c2e2-e063-6294a90a1327
spl set id: 1d142dba-145c-fb33-e063-6394a90a88b6

Reported adverse events (FAERS/openFDA)#

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