Label: INTENSIVE HEALING ANTI ITCH- hydrocortisone cream

  • 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 December 3, 2019

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  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • 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
  • 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.

  • 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
  • Other information

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

  • Questions or comments?

    1-800-719-9260

  • 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
  • INGREDIENTS AND APPEARANCE
    INTENSIVE HEALING ANTI ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0416
    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)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITE (Off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0416-11 in 1 CARTON03/20/2014
    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 not finalpart34803/20/2014
    Labeler - Rite Aid Corporation (014578892)
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