FDA.reportPublic FDA data

Proactiv Clean Acne Clearing Hydrator

Manufacturer
Alchemee, LLC | kdc/one Chatsworth, Inc.
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:41

Label at a glance#

ProductProactiv Clean Acne Clearing Hydrator
Active ingredientSALICYLIC ACID
Label structure10 sections

Dosage and administration

Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the management of acne                 

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Glyceryl Stearate SE, Propanediol, Cetyl Phosphate, Cetyl Alcohol, Stearic Acid, Dicaprylyl Carbonate, Undecane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Pentylene Glycol, Cetearyl Alcohol, Tridecane, Bakuchiol, Caprylyl Glycol, Xanthan Gum, Ethylhexylglycerin, Tocopheryl Acetate, Sodium Hyaluronate, Phenoxyethanol, Tocopherol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by
Alchemee LLC.
Santa Monica, CA 90401
Questions or comments?
1-800-950-4695
proactiv.com
Made in the USA of
foreign and domestic
components.
Proactiv is a trademark of
Taro Pharmaceuticals
U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 3 FL. OZ. (89 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®    

proactivclean TM

Acne Clearing
Hydrator

3 FL. OZ. (89 mL)

salicylic acid 
acne treatment

unit carton image
unit carton image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-458-00Proactiv Clean Acne Clearing Hydrator10 mL in 1 TUBEGEL103
11410-458-00Proactiv Clean Acne Clearing Hydrator1 in 1 BOXGEL13
11410-458-05Proactiv Clean Acne Clearing Hydrator30 mL in 1 TUBEGEL303
11410-458-10Proactiv Clean Acne Clearing Hydrator30 mL in 1 TUBEGEL303
11410-458-10Proactiv Clean Acne Clearing Hydrator1 in 1 BOXGEL13
11410-458-15Proactiv Clean Acne Clearing Hydrator1 in 1 BOXGEL13
11410-458-15Proactiv Clean Acne Clearing Hydrator89 mL in 1 TUBEGEL893

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-45811410-458-00, 11410-458-05, 11410-458-10, 11410-458-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
CETYL PHOSPHATEVT07D6X67OIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
UNDECANEJV0QT00NUEIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PENTYLENE GLYCOL50C1307PZGIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TRIDECANEA3LZF0L939IACT
BAKUCHIOLOT12HJU3ARIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
Proactiv Clean Acne Clearing HydratorSALICYLIC ACIDAlchemee, LLC33ac397c-55af-4a50-b5ce-80f8a88015812026-01-07WarningsExact identifier
ndc (package): 11410-458-05
ndc (package): 11410-458-15
ndc (package): 11410-458-10
ndc (package): 11410-458-00
ndc (product): 11410-458
ndc11 (package): 11410045805
ndc11 (package): 11410045810
ndc11 (package): 11410045815
ndc11 (package): 11410045800
spl id: 47d25d28-71f6-9f86-e063-6394a90ab328
spl set id: 33ac397c-55af-4a50-b5ce-80f8a8801581

Reported adverse events (FAERS/openFDA)#

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