Label: CORTISONE 10 INTENSIVE MOISTURE CREME- hydrocortisone cream

  • NDC Code(s): 41167-0022-0, 41167-0022-5
  • Packager: Chattem, Inc.
  • 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 13, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Cortizone 10 Intensive Moisture Creme

    Drug Facts

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    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, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-2, steareth-21, magnesium ascorbyl phosphate, chamomilla recutita (matricaria) flower extract, hydrolyzed jojoba esters, tocopheryl acetate, niacinamide, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, dimethicone, glyceryl stearate, hydroxyacetophenone, methyl gluceth-20, menthyl lactate, propylene glycol, ethylhexylglycerin, PPG-12/SMDI copolymer, disodium EDTA, beta-glucan (357-178)

  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH
    Cortizone 10
    INTENSIVE MOISTURE CREME
    1% Hydrocortisone
    Anti-Itch Creme
    Net wt 1 oz (28 g)

    MAXIMUM STRENGTH Cortizone 10 INTENSIVE MOISTURE CREME 1% Hydrocortisone Anti-Itch Creme Net wt 1 oz (28 g)

  • INGREDIENTS AND APPEARANCE
    CORTISONE 10 INTENSIVE MOISTURE CREME 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0022
    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)  
    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-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0022-01 in 1 CARTON01/01/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0022-51 in 1 CARTON01/01/2023
    256 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!