PROACTIV GENTLE FORMULA CLARIFYING CLEANSER- salicylic acid cream

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]

SPL UNCLASSIFIED SECTION

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

Benzoic Acid, Butylene Glycol, Cetearyl Alcohol, Cetyl Alcohol, Chlorphenesin, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Glycolic Acid, Isododecane, Linoleic Acid, Linolenic Acid, Morus Alba Root Extract, Neopentyl Glycol Diheptanoate, Paraffin, PEG-100 Stearate, Phenoxyethanol, Polysorbate 20, Saxifraga Sarmentosa Extract, Scutellaria Baicalensis Root Extract, Sodium Hyaluronate, Sodium Hydroxide, Sorbic Acid, Vitis Vinifera (Grape) Fruit Extract, Water, Xanthan Gum

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

INGREDIENTS AND APPEARANCE

PROACTIV GENTLE FORMULA CLARIFYING CLEANSER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-067
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
Benzoic Acid (UNII: 8SKN0B0MIM)
Butylene Glycol (UNII: 3XUS85K0RA)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetyl Alcohol (UNII: 936JST6JCN)
Chlorphenesin (UNII: I670DAL4SZ)
Edetate Disodium (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Glycolic Acid (UNII: 0WT12SX38S)
Isododecane (UNII: A8289P68Y2)
Linoleic Acid (UNII: 9KJL21T0QJ)
Linolenic Acid (UNII: 0RBV727H71)
Morus Alba Root (UNII: CST1G9BZGD)
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)
Paraffin (UNII: I9O0E3H2ZE)
Peg-100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
Saxifraga Stolonifera Leaf (UNII: O3TMV4903H)
Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Sodium Hydroxide (UNII: 55X04QC32I)
Sorbic Acid (UNII: X045WJ989B)
Wine Grape (UNII: 3GOV20705G)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-067-00	1 in 1 CARTON	10/01/2018
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	10/01/2018

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-067)