NDC | 27293-025-01, 27293-025-14 |
Set ID | 0acfb654-fa70-4887-a67c-dfbe950f431a |
Category | HUMAN OTC DRUG LABEL |
Packager | Budpak Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
-
wash affected area and dry thoroughly
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Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
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supervise children in the use of this product
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for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
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for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
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if conditions persist longer, ask a doctor
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this product is not effective on the scalp or nails.
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- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BUDPAK ANTIFUNGAL CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27293-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PETROLATUM (UNII: 4T6H12BN9U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27293-025-01 1 in 1 BOX 1 NDC:27293-025-14 14 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/17/2012 Labeler - Budpak Inc. (183224849) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(27293-025)