Label: ANTI ITCH- hydrocortisone cream

  • NDC Code(s): 11822-0499-1, 11822-0499-2, 11822-0499-3
  • Packager: Rite Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2024

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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

    •
    in the genital area if you have a vaginal discharge. Consult a doctor.
    •
    for the treatment of diaper rash. Consult 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 (1-800-222-1222).

  • 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, consult 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

    water, cetearyl alcohol, ceteareth-20, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, aloe barbadensis leaf juice

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient of Cortizone – 10® Creme

    MAXIMUM STRENGTH

    anti-itch cream

    relieves itch fast

    temporarily relieves skin irritation;

    inflammation & redness; rashes;

    insect bites; eczema & psoriasis

    1% hydrocortisone

    with soothing aloe

    NET WT 1 OZ (28 g)

    319-83-anti-itch-cream-1.jpg
    319-83-anti-itch-cream-2.jpg
  • INGREDIENTS AND APPEARANCE
    ANTI ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0499
    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)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0499-21 in 1 CARTON09/11/201303/31/2025
    156 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11822-0499-11 in 1 CARTON09/11/201304/30/2025
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:11822-0499-32 in 1 CARTON09/11/201303/31/2025
    356 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/11/201304/30/2025
    Labeler - Rite Aid Corporation (014578892)
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