Label: ANTI ITCH- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • Active Ingredient

    Hydrocortisone 1 %

  • Uses

    for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

    eczema

    seborrheic dermatitis

    psoriasis

    insect bites

    poison ivy, poison oak, and poison sumac

    cosmetics

    jewelry

    detergents

    soaps

    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

    When using this product

    do not get into the eyes

    Do not use

    for the treatment of diaper rash. Ask a doctor.

    Stop us and ask doctor if

    condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

    Keep out of reach of children

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

  • Directions

    adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

    children under 2 years: ask a doctor

  • Other information

    store at 20 °C to 25 °C (68 °F to 77 °F)

  • Inactive ingredient

    aloe barbadensis (aloe vera) leaf juice, anhydrous citric acid, avena sativa (oat) kernel extract, avena sativa (oat) kernel flour, avena sativa (oat) kernel oil, benzyl alcohol, ceteareth-20, cetostearyl alcohol, cetyl palmitate, cyclopentasiloxane, dimethicone/vinyltrimethylsiloxysilicate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben,
    polyoxyl 40 stearate, potassium lactate, purified water, sodium hydroxide, vitamin E

  • Purpose

    Anti-Itch

  • Content of labeling

    Principal Display Panel

    Compare to active ingredient in Aveeno 1% Hydrocortisone Anti-Itch Cream with triple Oats

    Helps relive severe itch from

    Eczema, poison Ivy, Psoriasis, insect bites, seborrheic dermatitis, detergents & soaps Poison oak & sumac

    Hydrocortisone Cream 1% with Oats, Aloe & vitamin E

  • INGREDIENTS AND APPEARANCE
    ANTI ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-292
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    VINYLTRIMETHYLSILYLOXY SILICATE (UNII: XZ65AY5QAK)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11383-292-0128 g in 1 TUBE; Type 0: Not a Combination Product02/10/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/10/2013
    Labeler - Weeks & Leo Co., Inc. (005290028)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(11383-292)
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