Label: CORTISONE 10 OVERNIGHT CREME- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 6, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Cortizone 10 Overnight Relief

    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

     temporarily relieves external anal and genital itching

     other uses of this product should only be under the advice and supervision of a doctor

  • Warnings

    For external use only

    Do not use

    ■ in the genital area if you have a vaginal discharge. Consult a doctor.

    ■ 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

     do not put directly into the rectum by using fingers or any mechanical device or applicator

    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

    ■ rectal bleeding occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ for itching of skin irritation, inflammation, and rashes:  

          ■ 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

     for external anal and genital itching, adults:

          ■ when practical, clean the affected area with mild soap and warm water and rinse thoroughly

          ■ gently dry by patting or blotting with toilet tissue or a soft cloth before applying

          ■ apply 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-2, steareth-21, beta-glucan, melatonin, methyl gluceth-20, hydroxyacetophenone, ethylhexylglycerin, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, hydrolyzed jojoba esters, propylene glycol, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, glyceryl stearate, menthyl lactate, EDTA, PPG-12/SMDI copolymer, potassium hydroxide, methylparaben, fragrance

  • PRINCIPAL DISPLAY PANEL

    Cortizone 10
    Overnight Crème
    Net
    wt 1 oz (28 g)

    PRINCIPAL DISPLAY PANEL
Cortizone 10
Overnight Crème
Net wt 1 oz (28 g)

  • INGREDIENTS AND APPEARANCE
    CORTISONE 10 OVERNIGHT CREME 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0109
    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)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    MELATONIN (UNII: JL5DK93RCL)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CHAMOMILE (UNII: FGL3685T2X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0109-21 in 1 CARTON01/01/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2023
    Labeler - Chattem, Inc. (003336013)