Label: CORTIZONE 10 INTENSIVE HEALING FEMININE ITCH RELIEF- hydrocortisone cream

  • NDC Code(s): 41167-0335-0, 41167-0335-1, 41167-0335-2
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Maximum Strength Cotizone 10®  Feminine Relief Anti-Itch Creme

    Drug Facts

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    • temporarily relieves external feminine itching
    • other uses of this product should only be under the advice and supervision of a doctor
  • Warnings

    For external use only

    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

    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly then gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product 
    • adults and children 12 years of age and older: apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • Inactive ingredients

    water, glycerin, dimethicone, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-21, steareth-2, chomomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, retinyl palmitate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, beta-glucan, glyceryl stearate, menthyl lactate, polysorbate 60, methyl gluceth-20, stearamidopropyl PG-dimonium chloride phosphate, PPG-12/SMDI copolymer, potassium hydroxide, diazolidinyl urea, propylene glycol, benzyl alcohol, methylparaben, BHT, propylparaben, EDTA (309-011) 

  • Principal Display Panel

    Maximum Strength
    Cotizone 10®
    FEMININE ITCH RELIEF
    Anti-Itch Crème
    For Feminine Itch
    1% Hydrocortisone Anti-Itch Creme
    Net wt 1 oz (28 g)

    Maximum Strength Cotizone 10® FEMININE ITCH RELIEF Anti-Itch Crème For Feminine Itch 1% Hydrocortisone Anti-Itch Creme Net wt 1 oz (28 g)

  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 INTENSIVE HEALING FEMININE ITCH RELIEF 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0335
    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)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0335-01 in 1 CARTON01/01/2014
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0335-21 in 1 CARTON01/01/201401/02/2014
    256 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41167-0335-11 in 1 CARTON01/01/201401/02/2014
    314 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2014
    Labeler - Chattem, Inc. (003336013)
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