Label: CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL- hydrocortisone cream

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

Drug Label Information

Updated May 31, 2024

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

  • SPL UNCLASSIFIED SECTION

    Cortizone 10 Itch Relief Massaging Rollerball

    Drug Facts

  • Active ingredient

  • Purpose

    Hydrocortisone 1%...........................................................................................................................................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

     other uses of this product should be only under the advice and supervision of a doctor

  • Warnings

    For external use only

    Do not use

    ■ for the treatment of diaper rash. Consult a doctor. 

    ■ if you are allergic to any ingredient in this product

    When using this product

     avoid contact with the eyes ■ do not use more than directed unless told to do so by a doctor

    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, 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.

  • Directions

    ■ 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

  • Inactive ingredients

    water, alcohol denat. (15%), dimethicone, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, ethylhexylglycerin, aloe barbadensis leaf juice, hydroxyacetophenone, glyceryl stearate, C30-45 alkyl cetearyl dimethicone crosspolymer, isohexadecane, acrylates/C10-30 alkyl acrylate crosspolymer, dicetyl phosphate, aminomethyl propanol, steareth-2, steareth-21, polysorbate 60, disodium EDTA, citric acid

  • PRINCIPAL DISPLAY PANEL

    Cortizone 10
    Itch Relief
    Massaging Rollerball 1.5 FL OZ (44.3 mL)

    PRINCIPAL DISPLAY PANEL
Cortizone 10 
Itch Relief 
Massaging Rollerball 1.5 FL OZ (44.3 mL)

    PRINCIPAL DISPLAY PANEL
Cortizone 10 
Itch Relief 
Massaging Rollerball 1.5 FL OZ (44.3 mL)

  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0338
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0338-01 in 1 CARTON01/02/2023
    142 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/02/2023
    Labeler - Chattem, Inc. (003336013)