Label: CORTIZONE 10 ANTI-ITCH FOR DIABETICS SKIN- hydrocortisone lotion

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

Drug Label Information

Updated October 25, 2023

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  • SPL UNCLASSIFIED SECTION

    Cotizone 10® Maximum Strength Anti-Itch Lotion for Diabetics' Skin

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

  • Principal Display Panel

    Cortizone 10®
    MAXIMUM STRENGTH
    anti-itch lotion for
    Diabetics' Skin
    fast, lasting relief
    to soothe dry, irritated skin
    1% Hydrocortisone
    Net wt 3.4 oz (96 g)

    Cortizone 10®
MAXIMUM STRENGTH
anti-itch lotion for
Diabetics' Skin
fast, lasting relief
to soothe dry, irritated skin
1% Hydrocortisone
Net wt 3.4 oz (96 g)

  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 ANTI-ITCH FOR DIABETICS SKIN 
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0342
    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)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OAT (UNII: Z6J799EAJK)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SHEANUT OIL (UNII: O88E196QRF)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    GINGER (UNII: C5529G5JPQ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0342-01 in 1 CARTON12/22/2014
    196 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/22/2014
    Labeler - Chattem, Inc. (003336013)