Label: DR. SHEFFIELD HYDROCORTISONE ANTI ITCH- hydrocortisone cream
- NDC Code(s): 11527-052-51, 11527-052-55
- Packager: Sheffield Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 30, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external feminine, genital and anal itching.
Other uses of this product should be only under the advice and supervision of a doctor.
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Warnings
For external use only
Do not use
- for the treatment of diaper rash, consult a doctor.
- for external genital itching if you have a vaginal discharge, consult a doctor.
When using this product
- avoid contact with eyes
- do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
- for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
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Directions
For external anal itching:
- adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
- children under 12 years of age with external anal itching: consult a doctor.
- Other information
- Inactive ingredients
- Principal Display Panel – 1oz Carton Label
- Principal Display Panel – 1oz Tube Label
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INGREDIENTS AND APPEARANCE
DR. SHEFFIELD HYDROCORTISONE ANTI ITCH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-052 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL PALMITATE (UNII: 5ZA2S6B08X) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-40 STEARATE (UNII: ECU18C66Q7) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-052-55 1 in 1 CARTON 07/10/2007 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11527-052-51 1 in 1 CARTON 07/10/2007 2 14 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 07/10/2007 Labeler - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(11527-052)
