Label: CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL- hydrocortisone cream

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

Drug Label Information

Updated November 6, 2023

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)

  • 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)