Label: ANTI ITCH- hydrocortisone cream

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

Drug Label Information

Updated January 8, 2025

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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
    •
    insect bites
    •
    poison ivy, oak, or sumac
    •
    soaps
    •
    detergents
    •
    cosmetics
    •
    jewelry
    •
    seborrheic dermatitis
    •
    psoriasis
    •
    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 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

    •
    rectal bleeding occurs
    •
    condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product unless you have asked a doctor

    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, ask a doctor
    •
    for external anal and genital itching, adults:
    •
    when practical, cleanse 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, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, ceteareth-20, diazolidinyl urea, sorbic acid, aloe barbadensis leaf juice, BHT, sodium hydroxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Signature SELECT™

    ANTI-ITCH CREAM

    HYDROCORTISONE 1% | MAXIMUM STRENGTH

    LOVE IT OR IT’S ON US

    Signature SELECT™

    ANTI-ITCH CREAM

    HYDROCORTISONE 1% | MAXIMUM STRENGTH

    NET WT 1 OZ (28 g)

    SIGNATURE SELECT ANTI-ITCH CREAM CARTON IMAGE 1 OF 2
    SIGNATURE SELECT ANTI-ITCH CARTON IMAGE 2 OF 2
  • INGREDIENTS AND APPEARANCE
    ANTI ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-433
    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
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SORBIC ACID (UNII: X045WJ989B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-433-641 in 1 CARTON12/29/2024
    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 DrugM01712/29/2024
    Labeler - Safeway (009137209)
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