Label: CORTIZONE 10 SENSITIVE SKIN ANTI-ITCH CREME- 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

    Sensitive Skin Anti-itch Creme

    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.

    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, or 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

    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, glycerin, dimethicone, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, dextrin, glyceryl stearate, isohexadecane, methyl gluceth-20, avena sativa (oat) kernel extract, tocopheryl acetate, magnesium ascorbyl phosphate, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, butyrospermum parkii (shea) butter extract, zingiber officinale (ginger) root extract, boswellia serrata gum, bisabolol, maltodextrin, ethylhexylglycerin, pentylene glycol, phenoxyethanol, disodium EDTA, dipropylene glycol, 4-t-butylcyclohexanol, benzoic acid, polysorbate 60, sodium citrate, citric acid

  • PRINCIPAL DISPLAY PANEL

    Sensitive Skin
    Itch Relief

    2 oz Size

    PRINCIPAL DISPLAY PANEL
Sensitive Skin
Itch Relief
2 oz Size

    Text

Description automatically generated

  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 SENSITIVE SKIN ANTI-ITCH CREME 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0336
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    OAT (UNII: Z6J799EAJK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GINGER (UNII: C5529G5JPQ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0336-01 in 1 CARTON01/01/2022
    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 DrugM01701/01/2022
    Labeler - Chattem, Inc. (003336013)