proactiv® Gentle Formula Clarifying Cleanser

Proactiv Gentle Formula Clarifying Cleanser by

Drug Labeling and Warnings

Proactiv Gentle Formula Clarifying Cleanser by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV GENTLE FORMULA CLARIFYING CLEANSER- salicylic acid cream 
THE PROACTIV COMPANY LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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proactiv® Gentle Formula Clarifying Cleanser

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

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 contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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.
• 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.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Distearyl Phthalic Acid Amide, Polyethylene, Cetyl Alcohol, Stearyl Alcohol, PEG-120 Methyl Glucose Dioleate, Ammonium Laureth Sulfate, Sodium Chloride, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Microcrystalline Wax, Butylene Glycol, Disodium EDTA, Sodium Hydroxide, Menthol, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Fragrance, Ferric Ferrocyanide, Blue 1

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 ● Within US 1-800-950-4695
Made in the USA of Foreign and Domestic Components
Proctiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 120 mL Carton

proactiv®             

Gentle Formula

clarifying
cleanser

1

salicylic acid acne medication

4 FL. OZ. 120 mL

PROACTIV GENTLE FORMULA CLARIFYING CLEANSER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.02 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Distearyl Phthalamic Acid (UNII: 5552GSZ9LI)
High Density Polyethylene (UNII: UG00KM4WR7)
Cetyl Alcohol (UNII: 936JST6JCN)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Ammonium Laureth-5 Sulfate (UNII: 43ZIH89I48)
Sodium Chloride (UNII: 451W47IQ8X)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Microcrystalline Wax (UNII: XOF597Q3KY)
Butylene Glycol (UNII: 3XUS85K0RA)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Hydroxide (UNII: 55X04QC32I)
Menthol (UNII: L7T10EIP3A)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Ethylparaben (UNII: 14255EXE39)
Butylparaben (UNII: 3QPI1U3FV8)
Propylparaben (UNII: Z8IX2SC1OH)
Isobutylparaben (UNII: 0QQJ25X58G)
Ferric Ferrocyanide (UNII: TLE294X33A)
Fd&c Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-501-40	1 in 1 CARTON	01/01/2003	12/02/2019
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2003	12/02/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-501)

Revised: 12/2017

Document Id: e5eddf92-121a-43d4-9834-fb55084b473a

34390-5

Set id: 410f212f-7893-48c2-8593-b7a06e1b58fc

Version: 3

Effective Time: 20171205