Label: PHISODERM CLEAN ANTI-BLEMISH BODY WASH- salicylic acid gel

  • NDC Code(s): 10742-1234-1
  • Packager: The Mentholatum Company
  • 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 February 7, 2023

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  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne treatment

  • Uses

    • for the treatment of acne
    • helps prevent new acne pimples from forming
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes. If contact occurs, flush thoroughly with water.
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • use daily in the shower or bath
    • massage over wet skin with a washcloth or body puff, concentrating on areas prone to breakouts
    • rinse thoroughly
  • Inactive ingredients

    water, sodium C14-16 olefin sulfonate, disodium cocoamphodiacetate, cocamidopropyl betaine, sodium methyl cocoyl taurate, glycerin, acrylates copolymer, aloe barbadensis leaf juice, butylene glycol, caprylyl/capryl glucoside, chamomilla recutita (matricaria) flower extract, citric acid, disodium EDTA, hydroxyphenyl propamidobenzoic acid, hydroxypropyltrimonium hyaluronate, melaleuca alternifolia (tea tree) leaf oil, pentylene glycol, potassium sorbate, sodium benzoate, sodium chloride, sodium hydroxide, tocopheryl acetate [vitamin E]

  • Questions?

    1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

  • Principal Display Panel

    pHisoderm Clean Anti-Blemish Body Wash
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    PHISODERM   CLEAN ANTI-BLEMISH BODY WASH
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    DIHYDROXYPROPYLTRIMONIUM (UNII: 925G44QFFO)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-1234-1295 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/02/2021
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-1234)
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