Label: INTENSIVE HEALING ANTI ITCH- hydrocortisone cream 

  • 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 03/14

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 itching associated with minor skin irritations, inflammation, and rashes due to:
    eczema
    psoriasis
    poison ivy, oak, sumac
    insect bites
    detergents
    jewelry
    cosmetics
    soaps
    seborrheic dermatitis
    temporarily relieves external anal and genital itching
    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. Ask a doctor.
    in the genital area if you have a vaginal discharge. Ask a doctor.

    When using this product

    avoid contact with the eyes
    do not use more than directed unless told to do so by a doctor
    do not put directly into the rectum by using fingers or any mechanical device or applicator

    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.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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: do not use, 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 tissue or a soft cloth before applying
    apply to affected area not more than 3 to 4 times daily
    children under 12 years of age: ask a doctor
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  • Other information

    store at 20°-25°C (68°-77°F)
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  • Inactive ingredients

    aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredient of Cortizone●10® Intensive Healing Formula

    MAXIMUM STRENGTH

    CLINICALLY PROVEN TO MOISTURIZE 24 HOURS

    intensive healing anti-itch cream

    relieves itch fast

    temporarily relieves dry, itchy skin, rashes, insect bites, eczema & psoriasis, inflammation, irritation & redness

    calms, nourishes, hydrates

    safe for sensitive skin

    1% hydrocortisone

    with antioxidants & chamomile

    NET WT 1 OZ (28 g)

    enriched with vitamins A, C & E

    Rite Aid Intensive Healing Anti-Itch Cream 1.jpg
    Rite Aid Intensive Healing Anti-Itch Cream 2.jpg
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  • INGREDIENTS AND APPEARANCE
    INTENSIVE HEALING ANTI ITCH 
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0416
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    OAT  
    BENZYL ALCOHOL  
    BUTYLATED HYDROXYTOLUENE  
    CETOSTEARYL ALCOHOL  
    CETYL ALCOHOL  
    CHAMOMILE  
    DIAZOLIDINYL UREA  
    DIMETHICONE  
    DISTEARYLDIMONIUM CHLORIDE  
    EDETATE DISODIUM  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    HYDROLYZED JOJOBA ESTERS (ACID FORM)  
    MAGNESIUM ASCORBYL PHOSPHATE  
    MENTHYL LACTATE, (-)-  
    METHYL GLUCETH-20  
    METHYLPARABEN  
    PETROLATUM  
    POLYSORBATE 60  
    POTASSIUM HYDROXIDE  
    PROPYLPARABEN  
    WATER  
    VITAMIN A PALMITATE  
    STEARETH-2  
    STEARETH-21  
    STEARYL ALCOHOL  
    Product Characteristics
    Color WHITE (Off white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0416-1 1 in 1 CARTON
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/20/2014
    Labeler - Rite Aid Corporation (014578892)
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