FDA.reportPublic FDA data

Proactiv Extra Strength Formula Cleanser

Manufacturer
THE PROACTIV COMPANY LLC | VEE PAK, LLC
Effective date
2018-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:44:31

Label at a glance#

ProductProactiv Extra Strength Formula Cleanser
Active ingredientBENZOYL PEROXIDE
Label structure7 sections

Dosage and administration

Sensitivity Test for 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 on the right. apply a small amount to dampened skin. 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 ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 8.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment gel

Use

INDICATIONS & USAGE SECTION

For the management of acne

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

OTC - ASK DOCTOR SECTION

OTC - WHEN USING SECTION

When using this product

  • skin irritation and dryness are 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 unnecessary sun exposure and use a sunscreen.
  • avoid contact with the eyes, lips, and mouth.
  • avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.  Irritation may be reduced by using the product less frequently or in lower concentration.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

OTC - STOP USE SECTION

Stop use and ask a doctor if
▪  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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Sensitivity Test for 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 on the right.
  • apply a small amount to dampened skin.
  • 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.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.                    

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, butylene glycol, coconut acid, dimethicone, ethylhexylglycerin, fragrance, glycerin, lauryl/myristyl benzoate, linoleic acid, linolenic acid, menthol, paraffin, phenoxyethanol, sodium cocoyl isethionate, sodium hydroxide, sodium isethionate, water

Questions or comments?
Within US 1-800-950-4695

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com
Made in the USA of Foreign and Domestic Components
Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 120 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®

EXTRA STRENGTH
FORMULA

cleanser

1                

benzoyl peroxide acne medication

4 FL. OZ. 120 mL

PABOX0014 ESF Cleanser
PABOX0014 ESF Cleanser

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-06611410-066-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked)59TL3WG5COIACT
Butylene Glycol3XUS85K0RAIACT
Coconut Acid40U37V505DIACT
Dimethicone92RU3N3Y1OIACT
Ethylhexylglycerin147D247K3PIACT
GlycerinPDC6A3C0OXIACT
Lauryl/Myristyl BenzoateN5RS934G6DIACT
Linoleic Acid9KJL21T0QJIACT
Linolenic Acid0RBV727H71IACT
MentholL7T10EIP3AIACT
ParaffinI9O0E3H2ZEIACT
PhenoxyethanolHIE492ZZ3TIACT
Sodium Cocoyl Isethionate518XTE8493IACT
Sodium Hydroxide55X04QC32IIACT
Sodium Isethionate3R36J71C17IACT
Water059QF0KO0RIACT

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
bbf80b81-b6c2-49bb-a807-1940b60a6618668fdccc-4f0d-42b9-b8a6-5da981e32c542022-12-15WarningsExact identifier
spl set id: 668fdccc-4f0d-42b9-b8a6-5da981e32c54

Reported adverse events (FAERS/openFDA)#

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