PROACTIV DEEP CLEANSING BODY WASH- salicylic acid lotion/shampoo
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 Deep Cleansing Body 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 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?
Within US 1-800-950-4695

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.

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11410-071-05	1 in 1 CARTON	02/01/2020	11/04/2023
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	11/04/2023
3	NDC:11410-071-15	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2020	11/04/2023
4	NDC:11410-071-20	1 in 1 CARTON	02/01/2020	01/20/2023
4		10 mL in 1 TUBE; Type 0: Not a Combination Product
5	NDC:11410-071-00	89 mL in 1 TUBE; Type 0: Not a Combination Product	11/02/2020	10/10/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	02/01/2020	11/04/2023

Labeler - Alchemee, LLC (080216357)

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

Revised: 12/2022

Document Id: 441dd0f3-3288-4d13-b763-bf578d7691a8

Set id: 83527aea-2de2-4752-b5ff-74ba17d34b4e

Version: 3

Effective Time: 20221222

Alchemee, LLC