PROACTIV DEEP CLEANSING BODY WASH- salicylic acid lotion/shampoo

Proactiv Deep Cleansing Body Wash by

Drug Labeling and Warnings

Proactiv Deep Cleansing Body 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 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.
• apply to dampened skin and gently massage.
• rinse thoroughly with warm water
• pat dry.
• if bothersome dryness or peeling occurs, reduce application use.
• may need to shake product before use.

Inactive Ingredients

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

Questions or comments?
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PRINCIPAL DISPLAY PANEL - 89 mL Carton

proactiv®

DEEP
CLEANSING
BODY WASH

3 FL. OZ. (89 mL)

salicylic acid acne treatment

Dist. by: The Proactiv Company LLC
El Segundo, CA 90245
proactiv.com ● Made in the USA
of Foreign and Domestic Components

Proactiv is a trademark of The Proactiv Company Sàrl.

INGREDIENTS AND APPEARANCE

PROACTIV DEEP CLEANSING BODY WASH 
salicylic acid lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-071
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)
Butylene Glycol (UNII: 3XUS85K0RA)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Caprylyl Glycol (UNII: 00YIU5438U)
Cetyl Alcohol (UNII: 936JST6JCN)
Chromium Hydroxide Green (UNII: RV8FT8XF5R)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Edetate Disodium (UNII: 7FLD91C86K)
Distearyl Phthalamic Acid (UNII: 5552GSZ9LI)
Ethylhexylglycerin (UNII: 147D247K3P)
Hexylene Glycol (UNII: KEH0A3F75J)
Hydrolyzed Jojoba Esters (acid Form) (UNII: UDR641JW8W)
Menthol (UNII: L7T10EIP3A)
Paraffin (UNII: I9O0E3H2ZE)
Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-071-05	1 in 1 CARTON	02/01/2020
1		89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 11410-071-10	267 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2020
3	NDC: 11410-071-15	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2020
4	NDC: 11410-071-20	1 in 1 CARTON	02/01/2020
4		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	02/01/2020

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-071)