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
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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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
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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
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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
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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
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INGREDIENTS AND APPEARANCE
CORTISONE 10 INTENSIVE MOISTURE CREME
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0022-0 1 in 1 CARTON 01/01/2023 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:41167-0022-5 1 in 1 CARTON 01/01/2023 2 56 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2023 Labeler - Chattem, Inc. (003336013)