Label: ACNE BODY WASH- salicylic acid gel

  • NDC Code(s): 58503-030-01
  • Packager: China Ningbo Shangge Cosmetic Technology Corp.
  • 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 12, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient                     Purpose

    Salicylic Acid 2% ............Acne Treatment

  • PURPOSE

    XtraCare 

    ACNE Body Wash

    Salicylic Acid

    Acne Medication

    • helps to fight body acne
    • for refresh & clean skin
    • enriched with aloe vera

    *Compare to Active Ingredients in Neutrogena Body Clear Body Wash

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    XtraCare Acne Body wash is refreshing, clean-rinsing body wash that helps fight acne on your back, chest, and shoulders. The foaming lather rinses completely without pore-clogging residue, leaving your skin feeling clean.

    Use

    for the treatment of acne.

  • DOSAGE & ADMINISTRATION

    Directions: Use daily in the shower or bath.  For maximum lather, massage over wet skin with a washcloth or body puff, concentrating on areas prone to breakouts. Rinse well.

  • WARNINGS

    Warning: for external use only.

    Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    When using this product avoid contact with eyes.  If contact occurs, flush thoroughly with water.

  • OTHER SAFETY INFORMATION

    Other information: Store at room temperature.

    *this product is not manufactured of distributed by Neutrogena Corp., owner of the registered trademark Body Clear® Body Wash.

    Distributed By:

    REJOICE INTERNATIONAL INC.

    NORTHVILLE, MI 48168, USA

    MADE IN CHINA

  • INACTIVE INGREDIENT

    Inactive Ingredients: water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, disodium cocoamphodiacetate, glycerin, cocamide MEA, fragrance, citric acid, aloe barbadensis leaf extract, methylchloroisothiazolinone, methylisothiazoline, FD&C yellow no.5, D&C red no.33

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    ACNE BODY WASH 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID7 mg  in 354 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-030-01354 mg in 1 BOTTLE; Type 0: Not a Combination Product11/18/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/18/2013
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-030)
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