Label: PHISODERM CLEAN ANTI-BLEMISH FACIAL CLEANSER- salicylic acid gel

  • NDC Code(s): 10742-1235-1
  • 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
  • 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

    • wet face, then gently massage cleanser onto skin
    • rinse well and pat dry
    • use twice daily
  • Inactive ingredients

    water, lauramidopropyl betaine, sodium C14-16 olefin sulfonate, lauryl glucoside, aloe barbadensis leaf juice, aminomethyl propanol, butylene glycol, caprylyl/capryl glucoside, carica papaya (papaya) fruit extract, chamomilla recutita (matricaria) flower extract, disodium EDTA, fragrance, glycerin, hydroxyphenyl propamidobenzoic acid, hydroxypropyltrimonium hyaluronate, pentylene glycol, potassium sorbate, sodium benzoate, sodium chloride, tocopheryl acetate [vitamin E]

  • Questions?

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

  • Principal Display Panel

    pHisoderm CLEAN ANTI-BLEMISH FACIAL CLEANSER
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    PHISODERM   CLEAN ANTI-BLEMISH FACIAL CLEANSER
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1235
    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)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    PAPAYA (UNII: KU94FIY6JB)  
    CHAMOMILE (UNII: FGL3685T2X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    DIHYDROXYPROPYLTRIMONIUM (UNII: 925G44QFFO)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-1235-1177 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(10742-1235)
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