Label: BASIC CARE HYDROCORTISONE- hydrocortisone cream

  • 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 February 6, 2019

If you are a consumer or patient please visit this version.

  • 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

    #1 Doctor Recommended Anti-Itch Active Ingredient

    Soothes Itch Fast

    Dry, Itchy Skin

    Skin Irritation & Rashes

    Eczema & Psoriasis

    Moisturizes While it Relieves

    Enriched with Aloe

    Compare to Cortizone • 10® Plus active ingredient

    Maximum Strength

    hydrocortisone 1% cream

    Anti-Itch Cream

    Relieves Itch Fast

    Plus 10 Moisturizers

    NET WT. 2 OZ (56 g)

    973-an-hydrocortisone-1.jpg
    973-an-hydrocortisone-2.jpg
  • INGREDIENTS AND APPEARANCE
    BASIC CARE HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0793
    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)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CORN OIL (UNII: 8470G57WFM)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0793-161 in 1 CARTON02/02/2018
    156 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 finalpart34802/02/2018
    Labeler - L. Perrigo Company (006013346)