Label: CORTIZONE 10 ULTRA SOOTHING CREME- hydrocortisone cream
- NDC Code(s): 41167-0027-0, 41167-0027-5
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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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, cetearyl alcohol, glycerin, petrolatum, mineral oil, isopropyl palmitate, sodium lauryl sulfate, beeswax, sodium cetearyl sulfate, methylparaben, tocopheryl acetate, propylparaben, propylene glycol, cetyl alcohol, aluminum sulfate, calcium acetate, dextrin, zea mays (corn) oil, cholecalciferol, retinyl palmitate, aloe barbadensis leaf Juice, maltodextrin (309-071)
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CORTIZONE 10 ULTRA SOOTHING CREME
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0027 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) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) SODIUM LAURYL SULFATE (UNII: 368GB5141J) YELLOW WAX (UNII: 2ZA36H0S2V) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL ALCOHOL (UNII: 936JST6JCN) ALUMINUM SULFATE (UNII: 34S289N54E) CALCIUM ACETATE (UNII: Y882YXF34X) CORN OIL (UNII: 8470G57WFM) CHOLECALCIFEROL (UNII: 1C6V77QF41) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALOE VERA LEAF (UNII: ZY81Z83H0X) MALTODEXTRIN (UNII: 7CVR7L4A2D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0027-5 1 in 1 CARTON 01/01/2023 1 56 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:41167-0027-0 1 in 1 CARTON 01/01/2023 2 28 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 Drug M017 01/01/2023 Labeler - Chattem, Inc. (003336013)
