Label: PROACTIV ACNE BODY WASH- salicylic acid liquid
- NDC Code(s): 11410-074-00, 11410-074-05, 11410-074-10, 11410-074-20
- Packager: Alchemee, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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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.
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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.
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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
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INGREDIENTS AND APPEARANCE
PROACTIV ACNE BODY WASH
salicylic acid liquidProduct 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 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 VEE PAK, LLC 874763303 manufacture(11410-074) 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)
