Label: ADVANCED ANTI-ITCH THERAPY- hydrocortisone soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 14, 2016

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  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Use

    ■ for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
    ■ eczema ■ poison ivy, oak, sumac ■ insect bites ■ detergents
    ■ jewelry ■ soaps ■ external genital and anal itching
    ■ other uses of this product should be only under the advice and supervision of a doctor

  • Warnings

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of the reach of children.
    • If swallowed, get medical help or contact a Poison Control Center immediately.
  • Directions

    adults and children 2 years of age and older:
    ■wash affected area not more than 3 to 4 times daily children under 2 years of age:
    ■do not use. Ask a doctor.

  • When using this product

    When using this product ■ avoid contact with the eyes.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if ■ condition worsens
    ■ symptoms persist for more than 7 days or clear up and occur again within a few days

  • Do not use

    Do not use ■ for external genital itching if you have a vaginal discharge. Ask a doctor

  • INACTIVE INGREDIENT

    Sodium Palmate, Sodium Cocoate, Water, Palmitic Acid, Glycerin, Sodium Chloride, Hydrogenated Jojoba Oil, Titanium Dioxide (CI 77891), Tetrasodium EDTA, Tetrasodium Etidronate

  • Questions?

    www.CVS.com

    1-800-SHOP CVS

  • Label

    Box

  • INGREDIENTS AND APPEARANCE
    ADVANCED ANTI-ITCH THERAPY 
    hydrocortisone soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-345
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-345-44119 g in 1 BOX; Type 0: Not a Combination Product06/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/10/2016
    Labeler - CVS Pharmacy, Inc. (062312574)
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