Label: CORTIZONE 10 FOR PSORIASIS- hydrocortizone lotion

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

Drug Label Information

Updated October 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Cortizone · 10® 
    Anti-Itch Lotion for Psoriasis

    Drug Facts

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    • temporarily relieves the itching and discomfort associated with minor skin irritations and rashes
    • other uses of this product should only be used 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 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, 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: ask a doctor
  • Inactive ingredients

    water, glycerin, petrolatum, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, glyceryl stearate, stearyl alcohol, isohexadecane, methyl gluceth-20, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter extract, avena sativa (oat) kernel extract, zingiber officinale (ginger) root extract, boswellia serrata gum, bisabolol, ceramide NP, ceramide NS, ceramide EOS, ceramide EOP, ceramide AP, caprooyl phytosphingosine, caprooyl sphingosine, magnesium ascorbyl phosphate, tocopheryl acetate, maltodextrin, polysorbate 60, phenoxyethanol, disodium EDTA, dipropylene glycol, ceteareth-25, cholesterol, behenic acid, pentylene glycol, methylparaben, 4-t-butylcyclohexanol, citric acid, sodium citrate

  • PRINCIPAL DISPLAY PANEL

    Cortizone 10®
    MAXIMUM STRENGTH
    anti-itch lotion for
    Psoriasis
    1% Hydrocortisone
    net wt 3.4 oz (96 g)

    Cortizone 10® MAXIMUM STRENGTH anti-itch lotion for Psoriasis 1% Hydrocortisone net wt 3.4 oz (96 g)

  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 FOR PSORIASIS 
    hydrocortizone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0341
    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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    OAT (UNII: Z6J799EAJK)  
    GINGER (UNII: C5529G5JPQ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    BISABOLOL OXIDE B, (-)- (UNII: S32G48306Y)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    CERAMIDE EOS (UNII: CR0J8RN66K)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    BEHENIC ACID (UNII: H390488X0A)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0341-096 g in 1 TUBE; Type 0: Not a Combination Product01/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/15/2016
    Labeler - Chattem, Inc. (003336013)
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