Label: ACNE CONTROL BODY WASH- salicylic acid wash soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 13, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid

    Two percent

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact physician or poison control center immediately.

  • Purpose

    Acne Treatment

  • QUESTIONS

    Call 844 425 4948

    Made in the USA

    Distributed by Clixit, LLC Orlando, FL

  • WARNINGS

    Warnings

    For external use only Using other topical acne medications at the same time may increase dryness or irritation of the skin

    If bothersome dryness or irritation occurs use only one medication unless directed by doctor

  • Use:

    For the treatment of acne.

  • DOSAGE & ADMINISTRATION

    Directions

    Use daily in shower or bath

    For maximum lather massage over wet skin with a washcloth sponge or body puff concentrating on areas of the body prone to breakout

    Rinse well

  • Other Ingredients:

    Acrylates Copolymer, Aloe Barbadensis, Cannabis Sativa (Hemp) Seed Oil, Capryl Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cocamidopropyl Betaine, Deionized Water, Ethylhexylglycerin, Glycerin, Glycolic Acid, Hexylene Glycol, Phenoxyethanol, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Tocopherol.

  • PRINCIPAL DISPLAY PANEL

    BODY WASH TUBE

    BodyWash_BOX

  • INGREDIENTS AND APPEARANCE
    ACNE CONTROL BODY WASH 
    salicylic acid wash soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-441
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3.4 g  in 168 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE (UNII: V5VD430YW9)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-441-021 in 1 BOX09/12/2019
    1NDC:76348-441-01168 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/12/2019
    Labeler - RENU LABORATORIES INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES INC945739449manufacture(76348-441)
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