Label: CORTIZONE 10 WATER RESISTANT- hydrocortisone ointment
- NDC Code(s): 41167-0344-0, 41167-0344-5
- 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
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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 time daily
- children under 2 years of age: ask a doctor
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 time daily
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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
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
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for itching of skin irritation, inflammation, and rashes:
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CORTIZONE 10 WATER RESISTANT
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0344 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 PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0344-5 1 in 1 CARTON 01/01/2023 1 56 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:41167-0344-0 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)