Label: CORTIZONE 10 ULTRA SOOTHING CREME- hydrocortisone cream

  • NDC Code(s): 41167-0027-0, 41167-0027-5
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 6, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Cortizone 10 Ultra Soothing Creme

    Drug Facts

  • Active ingredient

    Hydrocortisone1%

  • Purpose

    Anti-itch

  • Uses 

    temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

      eczema  psoriasispoison ivy, oak, sumac  insect bites  detergents  jewelry  cosmetics

       soaps  seborrheic dermatitis

     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

    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: 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

  • Inactive ingredients

    water, cetearyl alcohol, glycerin, petrolatum, mineral oil, isopropyl palmitate, sodium lauryl sulfate, beeswax, sodium cetearyl sulfate, methylparaben, tocopheryl acetate, propylparaben, propylene glycol, cetyl alcohol, aluminum sulfate, calcium acetate, dextrin, zea mays (corn) oil, cholecalciferol, retinyl palmitate, aloe barbadensis leaf Juice, maltodextrin (309-071)

  • Principal Display Panel

    Cortizone 10
    ULTRA SOOTHING CREME
    1% Hydrocortisone
    Anti-itch Creme
    Net wt 1 oz (28 g)

    Cortizone 10
ULTRA SOOTHING CREME
1% Hydrocortisone
Anti-Itch Creme
Net wt 1 oz (29 g)

  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 ULTRA SOOTHING CREME 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0027
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    CALCIUM ACETATE (UNII: Y882YXF34X)  
    CORN OIL (UNII: 8470G57WFM)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0027-51 in 1 CARTON01/01/2023
    156 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0027-01 in 1 CARTON01/01/2023
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2023
    Labeler - Chattem, Inc. (003336013)