Label: ANTI-ITCH PARABEN FREE- hydrocortisone cream

  • NDC Code(s): 11383-313-01, 11383-313-02
  • Packager: Weeks & Leo Co., Inc.
  • 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

    for external anal itching, do not use more than directed unless told to do so by a doctor

    do not put into the rectum by using fingers or any mechanical device or applicator

    Do not use

    for the treatment of diaper rash. Ask a doctor.

    for external genital itching if you have a vaginal discharge. Ask a doctor.

    for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

    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

    for external anal itching in adults:

    when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with an appropriate cleansing pad.

    gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

    for external anal itching in children under 12 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, cetearyl alcohol, glycerin, light mineral oil, potassium sorbate, purified water, sodium benzoate, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white wax

  • Purpose

    Anti-Itch

  • Content of labeling

    Principal Display PanelHydrocortisone Cream 1% with Aloe Vera

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH PARABEN FREE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-313
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11383-313-011 in 1 CARTON03/03/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11383-313-021 in 1 CARTON03/03/2023
    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 DrugM01703/03/2023
    Labeler - Weeks & Leo Co., Inc. (005290028)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(11383-313)
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