Label: CORTISONE- hydrocortisone lotion

  • Category: HUMAN OTC DRUG LABEL

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 November 21, 2019

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  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    •
    temporarily relieves itching associated with minor skin irritations, rashes, and inflammation due to eczema
    •
    other uses of this product should be only under the advice and supervision of a doctor
  • Warnings

    For external use only

  • Do not use

    •
    for the treatment of diaper rash. Consult a doctor.
  • When using this product

    •
    avoid contact with eyes
    •
    do not use more than directed unless told to do so by a doctor
  • Stop use and ask a doctor if

    •
    condition worsens, or if 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

    Keep out of reach of children.

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

  • Directions

    •
    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
  • Other information

    •
    store at 20-25°C (68-77°F)
    •
    contents filled by weight, not volume
  • Inactive ingredients

    aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serrata gum, butyrospermum parkii (shea butter) extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, edetate disodium, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, purified water, retinyl palmitate, sodium citrate, tocopheryl acetate, zingiber officinale (ginger) root extract

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to the active ingredient in Cortizone•10® Intensive Healing Lotion

    MAXIMUM STRENGTH

    Cortisone

    HYDROCORTISONE 1%

    Anti-itch lotion

    Long-lasting healing lotion

    Fast relief for eczema & dry, itchy skin

    With 7 intensive moisturizers

    Contains botanicals & antioxidant Vitamins A, C & E

    Hypoallergenic

    Clinically proven to moisturize 24 hours

    24 HOUR

    moisturizing

    NET WT 3.5 OZ (99 g)

    Cortisone Carton Image
  • INGREDIENTS AND APPEARANCE
    CORTISONE 
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-878
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OAT (UNII: Z6J799EAJK)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    GINGER (UNII: C5529G5JPQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-878-251 in 1 CARTON04/10/2012
    199 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 finalpart34804/10/2012
    Labeler - CVS Pharmacy (062312574)
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