Label: CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA- hydrocortisone lotion 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/09

If you are a consumer or patient please visit this version.

  • Active Ingredient:

    Hydrocortisone 1%

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  • Purpose

    Anti-itch

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  • Uses

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

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  • 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
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  • Other information

    • contents filled by weight, not volume
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  • Inactive Ingredients

    aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serata gum, butyrospermum parkii (shea) butter extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, disodium EDTA, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, retinyl palmitate, sodium citrate, tocopheryl acetate, water, singiber officinale (ginger) root extract (283-035) 

    *Clinically proven to moisturize for 24 hours

    **Refers to the ingredient hydrocortisone

    †Contains 7 healing moisturizers and vitamins A, C & E

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  • Principal Display Panel

    NEW!

    Fast, Lasting

    Itch Relief

    MAXIMUM STRENGTH

    Cortizone-10®

    INTENSIVE HEALING

    LOTION

    ECZEMA

    And Itchy, Dry Skin

    Dermatologist

    Recommended

    • 7 intensive moisturizers
    • Clinical strength*

     With

    Restora TM 

    Botanical &

    Vitamin Complex

    1% Hydrocortisone Anti-Itch Lotion

    DOCTORS

    #1 ITCH MEDICINE

    RECOMMEND

    Net wt 3.5 oz (99g)

    PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA 
    hydrocortisone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41167-0331
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    CETYL ALCOHOL  
    DIMETHICONE  
    DIPROPYLENE GLYCOL  
    EDETATE DISODIUM  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    MALTODEXTRIN  
    METHYLPARABEN  
    PETROLATUM  
    PHENOXYETHANOL  
    POLYSORBATE 60  
    PROPYLPARABEN  
    VITAMIN A PALMITATE  
    SODIUM CITRATE  
    .ALPHA.-TOCOPHEROL ACETATE, D-  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0331-0 1 in 1 CARTON
    1 99 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/08/2009
    Labeler - Chattem, Inc. (003336013)
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