Label: OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT- salicylic acid gel

  • 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 2.0% ............................. Acne Treatment

  • PURPOSE

    XtraCare Oil-Free Foaming Acne Wash Facial Cleanser

    PINK GRAPEFRUIT SCENT

    gentle cleansing for acne

    Salicylic Acid 2%

  • 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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • INDICATIONS & USAGE

    This XtraCare acne wash gently cleanses breakouts you already have and helps prevent them from returning. It works deep to clean and soothe without overdrying or irritating skin. Rinses clean, leaving no residue to clog pores.

  • WARNINGS

    Warnings

    For external use only.

    May stain some fabrics

    When using this product and other topical acne medications at the same time or immediately following use of this product, dryness or irritation of the skin may be increased.  If this occurs, only one medication should be used unless directed by a doctor.

  • DOSAGE & ADMINISTRATION

    Directions

    Wet face. Gently massage product all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Cleanse twice daily

  • INACTIVE INGREDIENT

    Inactive Ingredients: water, sodium c14-16 olefin sulfonate, cocamidopropyl betaine, acrylates copolymer, propylene glycol, sodium lauryl sulfate, fragrance, citric acid, aloe barbadensis leaf juice, disodium EDTA, sodium hydroxide, fd&c red no.33

  • OTHER SAFETY INFORMATION

    Other information

    store at 20o to 25oC (68o to 77oF)

    DISTRIBUTED BY

    REJOICE INTERNATIONAL INC

    48325 BINGHAMPTON DR

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER  GRAPEFRUIT
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID4 mg  in 177 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    PROPYLENE (UNII: AUG1H506LY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-033-01177 mg in 1 BOTTLE; Type 0: Not a Combination Product11/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/21/2013
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(58503-033)
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