PROACTIV ACNE BODY WASH- salicylic acid liquid

Proactiv Acne Body Wash by

Drug Labeling and Warnings

Proactiv Acne 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]

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. ▪ avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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.
• cover the entire affected area with a thin layer and rinse thoroughlyone 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

water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, synthetic wax, coco-betaine, acrylates copolymer, lauroyl/myristoyl methyl glucamide, sodium chloride, glycolic acid, olive oil PEG-8 esters, glycol distearate, fragrance, polyquaternium-39, laureth-4, coconut acid, mannitol, theobroma cacao (cocoa) seed butter, sodium hydroxide, prunus amygdalus dulcis (sweet almond) oil, butyrospermum parkii (shea) butter, microcrystalline cellulose, disodium EDTA, butylene glycol, chromium hydroxide green, tocopheryl acetate, aloe barbadensis leaf extract, hydroxypropyl methylcellulose 

Questions or comments?
1-800-950-4695

Distributed by Alchemee LLC
Santa Monica, CA 90401
Made in the USA of Foreign and
Domestic Components
Questions? 1-800-950-4695 proactiv.com

Proactiv is a registered trademark of
Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 89 mL

proactiv®

ACNE
BODY
WASH


3 FL. OZ. (89 mL)


salicylic acid acne medication

INGREDIENTS AND APPEARANCE

PROACTIV ACNE BODY WASH 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-074
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)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
OLIVE OIL GLYCERETH-8 ESTERS (UNII: 322K2STO13)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
LAURETH-4 (UNII: 6HQ855798J)
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)
COCONUT ACID (UNII: 40U37V505D)
MANNITOL (UNII: 3OWL53L36A)
COCOA BUTTER (UNII: 512OYT1CRR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALMOND OIL (UNII: 66YXD4DKO9)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
COCO-BETAINE (UNII: 03DH2IZ3FY)
LAUROYL/MYRISTOYL METHYL GLUCAMIDE (UNII: SC667B999P)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOLIC ACID (UNII: 0WT12SX38S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-074-00	1 in 1 CARTON	06/02/2020
1		10 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-074-05	89 mL in 1 TUBE; Type 0: Not a Combination Product	06/02/2020
3	NDC: 11410-074-10	267 mL in 1 TUBE; Type 0: Not a Combination Product	06/02/2020
4	NDC: 11410-074-20	1 in 1 BOX	01/01/2022
4		89 mL in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 11410-074-15	475 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	06/02/2020

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
Apex International Mfg LLC		079110793	manufacture(11410-074)

Establishment
Name	Address	ID/FEI	Business Operations
kdc/one Chatsworth, Inc.		118542196	manufacture(11410-074)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-074)