FDA.reportPublic FDA data

Proactiv ® Blackhead Dissolving Gel

Manufacturer
Alchemee, LLC | Apex International Mfg LLC | VEE PAK, LLC
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:31:47

Label at a glance#

ProductProactiv Blackhead Dissolving
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 uses. 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 and rinse thoroughly  one to three times daily because excessive drying of the skin may occur, start with one application daily, then...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 0.5%

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 uses. 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 and rinse thoroughly 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, dimethicone, cyclopentasiloxane, glycereth-26, glycerin, cyclohexasiloxane, PEG-80 sorbitan laurate, dimethiconol, polyacrylate-13, panthenol, phenoxyethanol, fragrance, polyisobutene, caprylyl glycol, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, hexylene glycol, ethylhexylglycerin, bisabolol, lactic acid, polysorbate 20, ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, ethylhexyl salicylate, camellia sinensis leaf extract

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 - 30 mL Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®

BLACKHEAD
DISSOLVING
GEL

1 FL. OZ. 30 mL

salicylic acid acne medication

unit carton image
unit carton image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252296salicylic acid 0.5 % Topical GelPSN4
252296salicylic acid 0.005 MG/MG Topical GelSCD4
252296salicylic acid 0.5 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-024-05Proactiv Blackhead Dissolving30 mL in 1 TUBEGEL304
11410-024-05Proactiv Blackhead Dissolving1 in 1 BOXGEL14

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-02411410-024-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERETH-26NNE56F2N14IACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 6XHK3U310BAIACT
DIMETHICONOL (40 CST)343C7U75XWIACT
PANTHENOLWV9CM0O67ZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
LEVOMENOL24WE03BX2TIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
POLYISOBUTYLENE (1300 MW)241BN7J12YIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
POLYSORBATE 207T1F30V5YHIACT
PPG-26-BUTETH-262II1K6TZ4PIACT
AVOBENZONEG63QQF2NOXIACT
OCTINOXATE4Y5P7MUD51IACT
OCTISALATE4X49Y0596WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (1300000 MW)SC5Y4X78TGIACT
PEG-80 SORBITAN LAURATE239B50Y732IACT
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 Blackhead DissolvingSALICYLIC ACIDAlchemee, LLC822c64b9-59bd-4625-b4bf-294d54c96e102026-01-07WarningsExact identifier
ndc (package): 11410-024-05
ndc (product): 11410-024
ndc11 (package): 11410002405
spl id: 47d28d21-3105-8b9d-e063-6294a90a3643
spl set id: 822c64b9-59bd-4625-b4bf-294d54c96e10

Reported adverse events (FAERS/openFDA)#

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