Label: CORTISONE 10 OVERNIGHT CREME- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 21, 2022

If you are a consumer or patient 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 not finalpart34801/01/2023
    Labeler - Chattem, Inc. (003336013)