FDA.reportPublic FDA data

Proactiv Advanced Daily Oil Control

Manufacturer
Alchemee, LLC | Apex International Mfg LLC | VEE PAK, LLC
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:31:47

Label at a glance#

ProductProactiv Advanced Daily Oil Control
Active ingredientSALICYLIC ACID
Label structure8 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 ...

Label contents#

Full prescribing information#

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 - STOP USE SECTION

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, alcohol denat., butylene glycol, cyclopentasiloxane, nylon-12, glyceryl stearate, PEG-100 stearate, PVM/MA decadiene crosspolymer, aluminum starch octenylsuccinate, cyclohexasiloxane, caprylyl glycol, decylene glycol, phenoxyethanol, sodium hydroxide, hexylene glycol, fragrance, disodium EDTA, pentylene glycol, sebacic acid, 10-hydroxydecanoic acid, 1,10-decanediol, sarcosine, xanthan gum

Questions or comments?
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 - 75 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 
proactiv ®                     

ADVANCED
DAILY
OIL CONTROL

2.5 FL. OZ. 75 mL

salicylic acid acne medication           

unit carton image
unit carton image

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-055-00Proactiv Advanced Daily Oil Control1 in 1 BOXLOTION15
11410-055-00Proactiv Advanced Daily Oil Control75 mL in 1 TUBELOTION755
11410-055-05Proactiv Advanced Daily Oil Control1 in 1 BOXLOTION15
11410-055-05Proactiv Advanced Daily Oil Control22 mL in 1 TUBELOTION225

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-05511410-055-00, 11410-055-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
NYLON-12446U8J075BIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
CYCLOMETHICONE 6XHK3U310BAIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
DECYLENE GLYCOLS57M60MI88IACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
PENTYLENE GLYCOL50C1307PZGIACT
10-HYDROXYDECANOIC ACIDNP03XO416BIACT
SEBACIC ACID97AN39ICTCIACT
1,10-DECANEDIOL5I577UDK52IACT
SARCOSINEZ711V88R5FIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALCOHOL3K9958V90MIACT
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 Advanced Daily Oil ControlSALICYLIC ACIDAlchemee, LLC945be4e4-1ca2-41df-b3c8-da7b8fe38bc42026-01-07WarningsExact identifier
ndc (package): 11410-055-00
ndc (package): 11410-055-05
ndc (product): 11410-055
ndc11 (package): 11410005505
ndc11 (package): 11410005500
spl id: 47d28c49-56d8-75a1-e063-6294a90a03c5
spl set id: 945be4e4-1ca2-41df-b3c8-da7b8fe38bc4

Reported adverse events (FAERS/openFDA)#

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