Proactiv® Deep Cleansing Wash

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 Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV DEEP CLEANSING WASH- salicylic acid lotion/shampoo 
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® Deep Cleansing Wash

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?

Within US 1-800-950-4695

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 267 mL Tube Label

proactiv®

DEEP
CLEANSING
WASH

9 FL. OZ. 267 mL

salicylic acid
acne medication

PROACTIV DEEP CLEANSING WASH 
salicylic acid lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-039
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)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)
PARAFFIN (UNII: I9O0E3H2ZE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
COCONUT ACID (UNII: 40U37V505D)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
SODIUM SULFITE (UNII: VTK01UQK3G)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-039-16	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2017	12/02/2019
2	NDC: 11410-039-18	720 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2017	12/02/2019
3	NDC: 11410-039-25	89 mL in 1 TUBE; Type 0: Not a Combination Product	03/10/2017	12/02/2019
4	NDC: 11410-039-97	267 mL in 1 TUBE; Type 0: Not a Combination Product	03/10/2017	12/02/2019
5	NDC: 11410-039-98	1 in 1 BOX	03/10/2017	12/02/2019
5		267 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	03/10/2017	12/02/2019

Labeler - The Proactiv Company, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
Vee Pak Inc.		874763303	MANUFACTURE(11410-039)

Revised: 3/2017

Document Id: 5774768d-fb22-4709-97cf-e1f70aaf6eca

34390-5

Set id: a6e08789-1a4c-48a6-93aa-245aeff37db7

Version: 2

Effective Time: 20170313

 

The Proactiv Company, LLC