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

  • NDC Code(s): 58503-031-01
  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                        Purpose

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

  • PURPOSE

    Oil-Free Foaming Acne Wash Facial Scrub

    Pink Grapefruit Scent

    helps clear breakouts

    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 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 occurse, 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.

  • INACTIVE INGREDIENT

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

  • OTHER SAFETY INFORMATION

    Other Information

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

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    OIL-FREE FOAMING ACNE WASH 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-031
    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)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-031-01150 g 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(58503-031)