PROACTIV DEEP CLEANSING WASH- salicylic acid lotion/shampoo

Proactiv Deep Cleansing Wash by

Drug Labeling and Warnings

Proactiv Deep Cleansing Wash 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.  Shake before use.
• because excessive drying of the skin may occur, start with one application every other day, then gradually increase to one application daily or as directed by a doctor.
• if bothersome dryness or peeling occurs, reduce application use to every other day.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Distearyl Phthalic Acid Amide, Paraffin, Stearyl Alcohol, Cetyl Alcohol, Jojoba Esters, Sodium Chloride, Sodium Methyl Cocoyl Taurate, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Coconut Acid, Menthol, PEG-120 Methyl Glucose Dioleate, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, Ascorbic Acid, Citric Acid, Butylene Glycol, Disodium EDTA, Isopropyl Alcohol, Sodium Hydroxide, Phenoxyethanol, Sodium Benzoate, Sodium Sulfite, Potassium Sorbate, Fragrance, Chromium Hydroxide Green

Questions or comments?
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PRINCIPAL DISPLAY PANEL - 89 mL Carton

proactiv®

DEEP
CLEANSING
WASH

3 FL. OZ. 89 mL

salicylic acid acne treatment

Dist. 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 - 267 mL Tube

proactiv®

DEEP
CLEANSING
WASH

9 FL. OZ. 267 mL

salicylic acid acne medication

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 - 475 mL Tube

proactiv®

DEEP
CLEANSING
WASH

16 FL. OZ. 475 mL

salicylic acid acne medication

INGREDIENTS AND APPEARANCE

PROACTIV DEEP CLEANSING WASH 
salicylic acid lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-048
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
Water (UNII: 059QF0KO0R)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Distearyl Phthalamic Acid (UNII: 5552GSZ9LI)
Paraffin (UNII: I9O0E3H2ZE)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Cetyl Alcohol (UNII: 936JST6JCN)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Coconut Acid (UNII: 40U37V505D)
Menthol (UNII: L7T10EIP3A)
Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Caprylyl Glycol (UNII: 00YIU5438U)
Hexylene Glycol (UNII: KEH0A3F75J)
Ethylhexylglycerin (UNII: 147D247K3P)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Butylene Glycol (UNII: 3XUS85K0RA)
Edetate Disodium (UNII: 7FLD91C86K)
Isopropyl Alcohol (UNII: ND2M416302)
Sodium Hydroxide (UNII: 55X04QC32I)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Sulfite (UNII: VTK01UQK3G)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Chromium Hydroxide Green (UNII: RV8FT8XF5R)
Hydrolyzed Jojoba Esters (acid Form) (UNII: UDR641JW8W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-048-05	1 in 1 CARTON	10/01/2010
1		89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 11410-048-10	267 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2010
3	NDC: 11410-048-15	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2010
4	NDC: 11410-048-00	720 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2010	04/30/2019
5	NDC: 11410-048-20	1 in 1 CARTON	03/01/2019
5		10 mL in 1 TUBE; 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	10/01/2010

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-048)