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 
Alchemee, 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 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.

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.
• gently massage dime-sized amount into dampened skin.
• rinse thoroughly with warm water and pat dry.
• use daily (morning and night).

Inactive Ingredients

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

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

Distributed by The Proactiv Company LLC
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: 11410-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Ammonium Laureth-2 Sulfate (UNII: 698O4Z48G6)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Butylene Glycol (UNII: 3XUS85K0RA)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Caprylyl Glycol (UNII: 00YIU5438U)
Cetyl Alcohol (UNII: 936JST6JCN)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Edetate Disodium (UNII: 7FLD91C86K)
Distearyl Phthalamic Acid (UNII: 5552GSZ9LI)
Ethylhexylglycerin (UNII: 147D247K3P)
Ferric Ferrocyanide (UNII: TLE294X33A)
Hexylene Glycol (UNII: KEH0A3F75J)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Microcrystalline Wax (UNII: XOF597Q3KY)
Paraffin (UNII: I9O0E3H2ZE)
Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-072-00	1 in 1 CARTON	07/01/2020	06/12/2022
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	07/01/2020	06/12/2022

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-072)

Revised: 12/2022

Document Id: 8cd6f2eb-9e3e-4f31-a638-df970f236da2

34390-5

Set id: fbb35c9f-7f9d-427a-8986-f0852d6580f8

Version: 2

Effective Time: 20221215