NDC | 11527-071-40 |
Set ID | b8b8e6b2-1022-4592-91ba-3cf94c7cf318 |
Category | HUMAN OTC DRUG LABEL |
Packager | Sheffield Pharmaceuticals LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.
- Supervise children in the use of this product.
- For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
- If conditions persist longer, consult a doctor.
- This product is not effective on the scalp or nails.
- Other information
- Inactive ingredients
- Questions
- Principal Display Panel – 1.25oz Tube
- Principal Display Panel – 1.25oz Carton
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INGREDIENTS AND APPEARANCE
DR SHEFFIELD ATHLETES FOOT
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-071 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) BENZYL ALCOHOL (UNII: LKG8494WBH) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) OCTYLDODECANOL (UNII: 461N1O614Y) CETYL PALMITATE (UNII: 5ZA2S6B08X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-071-40 1 in 1 CARTON 10/04/2004 1 35.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11527-071-15 1 in 1 CARTON 12/22/2020 2 15 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:11527-071-30 1 in 1 CARTON 12/22/2020 3 30 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 final part333C 10/04/2004 Labeler - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(11527-071)