NDC | 45802-434-01, 45802-434-11 |
Set ID | 3dcd0158-ec51-4fa7-a26a-02c2926156c0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Padagis Israel Pharmaceuticals Ltd |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
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- wash the affected area and dry thoroughly
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- apply a thin layer over affected area twice daily (morning and night)
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- supervise children in the use of this product
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- 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
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- for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
- •
- if condition persists longer, consult a doctor
- •
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-434 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ESTERS WAX (UNII: D072FFP9GU) OCTYLDODECANOL (UNII: 461N1O614Y) POLYSORBATE 60 (UNII: CAL22UVI4M) WATER (UNII: 059QF0KO0R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-434-01 1 in 1 CARTON 06/03/2011 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:45802-434-11 1 in 1 CARTON 06/09/2011 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 final part333C 06/03/2011 Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)