Label: SHOPKO HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream
- NDC Code(s): 37012-059-02
- Packager: Shopko Stores Operating Co., LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 5, 2024
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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 be only under the advice and supervision of a doctor
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
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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 times daily
- children under 2 years of age: ask a doctor
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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
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for itching of skin irritation, inflammation, and rashes:
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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INGREDIENTS AND APPEARANCE
SHOPKO HYDROCORTISONE MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-059 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-059-02 1 in 1 CARTON 08/23/1995 1 28.4 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 08/23/1995 Labeler - Shopko Stores Operating Co., LLC (023252638) Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 manufacture(37012-059)
