Label: CVS COOLS ITCH FAST- hydrocortisone gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • ACTIVE INGREDIENT

    Active ingredients                             Purpose

    Hydrocortisone 1%......................... Anti-itch

  • PURPOSE

    Uses for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

    • eczema
    • insect bites
    • poison ivy
    • posion oak
    • poison sumac
    • soaps
    • jewlery
    • detergents
    • cosmetics
    • psoriasis
    • seborrheic dematitis
    • temporarily relievs external anal and genital itching
    • other uses of this product should be only under the advice and supervision of a doctor
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • in the genital area if you have a vaginal discharge. Consult a doctor.
    • for the treatment of diaper rash. Consult a doctor.
    • more than directed unless directed by a doctor
  • WHEN USING

    When using this product

    • avoid contact with the eyes
    • do not put directly into the rectum by using fingers or any mechanical device or applicator
  • STOP USE

    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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
    • rectal bleeding occurs
  • 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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • INDICATIONS & USAGE

    Directions

    • for itching of skin irritation, inflammation, and rashes:
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
    • for external anal and genital itching, adults:
    • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissure or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera leaf, carboxypolymethylene, glycerin, methylparaben, oat kernel oil, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol, water, white wax

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    ONE CVS DRIVE

    WOONSOCKET, RI 02895 USA

  • PRINCIPAL DISPLAY PANEL

    28397

  • INGREDIENTS AND APPEARANCE
    CVS COOLS ITCH FAST 
    hydrocortisone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-729
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-729-281 in 1 PACKAGE10/13/2014
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/13/2014
    Labeler - CVS Pharmacy, Inc. (062312574)