Label: OIL-FREE FOAMING ACNE WASH TEA TREE OIL- salicylic acid gel

  • NDC Code(s): 58503-032-01, 58503-032-02
  • 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 May 19, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient                             Purpose

    Salicylic Acid 2.0% ................. Acne Treatment

  • PURPOSE

    XtraCare Oil-Free Foaming Acne Wash Facial Scrub

    WITH TEA TREE OIL

    helps clear breakouts

    Salicylic Acid 2%

    Net Wt 5.3 Oz (150g)

  • 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 foaming acne facial scrub 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.

    Uses

    For acne-prone skin.

  • WARNINGS

    Warnings

    For external use only

    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. Dispense into palm, apply to face and massage gently. Rinse thoroughly and pat dry.

  • 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

  • Inactive ingredients

    water, sodium c14-16 olefin sulfonate, cocamidopropyl betaine, acrylates copolymer, sodium chloride, microcrystalline wax, DMDM hydantoin, fragrance, disodium EDTA, sodium lauryl sulfate, sodium hydroxide, propylene glycol, melaleuca altemifolia (tea tree) leaf oil, fd&c blue no.1, fd&c yellow no.5.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    OIL-FREE FOAMING ACNE WASH  TEA TREE OIL
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-032-0150 g in 1 BOTTLE; Type 0: Not a Combination Product11/20/201305/19/2023
    2NDC:58503-032-02150 g in 1 BOTTLE; Type 0: Not a Combination Product11/20/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/20/2013
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-032)
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