Label: ANTI ITCH MAXIMUM STRENGTH PLUS- hydrocortisone cream

  • NDC Code(s): 11822-0680-1, 11822-0680-2
  • Packager: Rite Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 August 28, 2017

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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 be only 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. Ask a doctor.
    •
    for the treatment of diaper rash. 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, aluminum sulfate, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, light mineral oil, maltodextrin, methylparaben, propylene glycol, propylparaben, purified water, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopherol, white petrolatum, white wax, zea mays (corn) oil

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient of Cortizone–10® Plus

    MAXIMUM STRENGTH PLUS

    relieves itch fast

    anti-itch cream

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

    1% hydrocortisone

    NET WT 2 OZ (56 g)

    enriched with aloe plus vitamin A & E

    973-83-anti-itch cream-1.jpg
    973-83-anti-itch cream-2.jpg
  • INGREDIENTS AND APPEARANCE
    ANTI ITCH  MAXIMUM STRENGTH PLUS
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0680
    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)  
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    CALCIUM ACETATE (UNII: Y882YXF34X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CORN OIL (UNII: 8470G57WFM)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0680-21 in 1 CARTON02/16/2011
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11822-0680-11 in 1 CARTON02/16/2011
    256 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 finalpart34802/16/2011
    Labeler - Rite Aid Corporation (014578892)
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