Label: CVS ANTI-ITCH HYDROCORTISONE- hydrocortisone cream

  • 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 September 12, 2016

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  • ACTIVE INGREDIENT

    Avtive ingredient                                Purpose

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

  • PURPOSE

    Uses

    Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

    • eczema
    • insect bites
    • poison ivy, oak, or sumac
    • soaps and detergents
    • cosmetics
    • jewlery
    • seborrheic dematitis
    • psoriasis
    • other use of this product; ask a doctor
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • in or near the eyes
    • for diaper rash: ask a doctor
  • ASK DOCTOR

    Ask a doctor before use if you are using any other hydrocoritsone product

  • STOP USE

    Stop use and ask a doctor

    • condition worsens or if symptoms persist for more than 7 days
    • symptoms last more than 7 days or clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions

    • apply to affected area no more than 3 to 4 times daily
    • children under 2 years, do not use: ask a doctor
  • STORAGE AND HANDLING

    Other information

    Store at room temperature. Protect from freezing and excessive heat.

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera leaf, avena sativa (oat) kennel extract, avena sativa (oat) kennel flour, avena sativa (oast) kernel oil, benzyl alcohol, cetearth-20, cetearyl alcohol, cetyl palmitate, chrysanthemum parthenium (feverfew) extract, citric acid, cyclopentasiloxane, dimethicone, dimethyl MEA, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, PEG-40 stearate, potassium lactate, tocopherol acetate, water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    ONE CVS DRIVE

    WOONSOCKET, RI 02895 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CVS ANTI-ITCH HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-844
    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)  
    OAT (UNII: Z6J799EAJK)  
    OATMEAL (UNII: 8PI54V663Y)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DEANOL (UNII: 2N6K9DRA24)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOSTEARYL MYRISTATE (UNII: H3VX9DDD0O)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-844-281 in 1 PACKAGE09/12/2016
    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 not finalpart34802/25/2014
    Labeler - CVS Pharmacy, Inc. (062312574)
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