NDC | 54633-214-01 |
Set ID | a003130b-77f7-4d42-8e7f-edd55176f013 |
Category | HUMAN OTC DRUG LABEL |
Packager | The Podiatree Company |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask a doctor or pharmacist if
- KEEP OUT OF REACH OF CHILDREN.
-
Directions
• wash affected area and dry thoroughly
• apply one drop to the affected area twice daily (morning and night) or as directed by your doctor
• using a disposable cotton swab, spread a thin layer over the affected area
• discard cotton swab
• supervise children in the use of this product
• for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• for athlete’s foot and ringworm infections, use daily for 4 weeks
• this product is not effective on scalp or nails - Other Information
- Inactive Ingredients
- Questions or Suggestions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FORTINIA
clotrimazole 1% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54633-214 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 mL Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) LAVENDER OIL (UNII: ZBP1YXW0H8) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WHEAT GERM OIL (UNII: 14C97E680P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54633-214-01 29.57 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/01/2014 Labeler - The Podiatree Company (078656000)