Label: HYDROCORTISONE shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 2, 2019

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  • DOSAGE & ADMINISTRATION

    Wet hair thoroughly. apply shampoo, generously lather scalp for several minutes. Rinse thoroughly. repeat.Follow with Step 2 Dr. Marder Scalp Therapy total Relief Conditioner. Use Daily if needed.

  • WARNINGS

    For external use only.

    When using this product avoid contact with eyes.

  • ACTIVE INGREDIENT

    Hydrocortisone 1%

  • INACTIVE INGREDIENT

    HEXYLENE GLYCOL

    POTASSIUM SORBATE

    SODIUM C14-16 OLEFIN SULFONATE

    WATER

    ASCORBIC ACID

    BIOTIN

    CAFFEINE

    CAMELLIA SINENSIS SEED OIL

    CAPRYLYL GLYCOL

    COCAMIDOPROPYL BETAINE

    XANTHAN GUM

    DECYL GLUCOSIDE

    PANTHENOL

    GLYCERIN

    LAURYL GLUCOSIDE

    LECITHIN, SOYBEAN

    METHYLISOTHIAZOLINONE

    PHENOXYETHANOL

    PROPYLENE GLYCOL

    RESVERATROL

    VITAMIN A PALMITATE

    SODIUM METABISULFITE

    ALPHA-TOCOPHEROL ACETATE

    GLYCOL STEARATE

    COCONUT OIL

  • PURPOSE

    Anti-Itch Liquid

  • 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.

  • INDICATIONS & USAGE

    Helps control the symptoms of scalp itch associated with minor skin irritations and rashes due to

    • Seborrheic Dermatitis
    • Eczema
    • Psoriasis
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71516-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BIOTIN (UNII: 6SO6U10H04)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    RESVERATROL (UNII: Q369O8926L)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71516-001-01180 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/14/2017
    Labeler - Dr Marder Skincare LLC (146890103)
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