Label: ANTI-FUNGAL- anti-fungal shampoo shampoo

  • NDC Code(s): 87255-008-01
  • Packager: Shenzhen Mengyue Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2026

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  • ACTIVE INGREDIENT

    Ketoconazole 1%

  • PURPOSE

    Anti-Fungal shampoo

  • Uses

    controls flaking, scaling and itching associated with dandruff

  • Warnings

    For external use only

  • Do not use

    - on scalp that is broken or inflamed

    - if you are allergic to ingredients in this product

  • When using this product

    - avoid contact with eyes

    - if product gets into eyes,rinse thoroughly with water

  • Stop use and ask a doctor if

    - rash appears

    - condition worsens or does not improve in 2-4 weeks

  • KEEP OUT OF REACH OF CHILDREN

    If pregnant or breast-feeding, ask a doctor before use.

    Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years and over

    - wet hair thoroughly

    - apply shampoo, generously lather, rinse thoroughly.Repeat

    - use every 3-4 days for up to 8 weeks or as directed by a doctor.Then use only as needed to control dandruff

    children under 12 years

    - ask a doctor

  • Other information

    - store at 20℃ to 25℃(68°F-77°F)

    - see top panel for lot number and expiration date

  • Inactive ingredients

    blue l, citric acid, cocamide MEA. mentha Piperita Oil.glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7.sodium benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, tetrasodium EDTA, water

  • PRINCIPAL DISPLAY PANEL

    87255-008-01

  • INGREDIENTS AND APPEARANCE
    ANTI-FUNGAL 
    anti-fungal shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:87255-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)  
    COCAMIDE MEA (UNII: C80684146D)  
    POLYQUATERNIUM-7 (UNII: 0L414VCS5Y)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    DISPERSE BLUE 1 (UNII: 2429NAZ8WH)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM COCOYL SARCOSINATE (UNII: 1R9DUY89CZ)  
    TETRASODIUM EDTA (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:87255-008-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03201/12/2026
    Labeler - Shenzhen Mengyue Technology Co., Ltd. (511200055)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Mengyue Technology Co., Ltd.511200055manufacture(87255-008)
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