Label: FORTINIA OF- clotrimazole 1% solution
- NDC Code(s): 54633-017-01
- Packager: The Podiatree Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 20, 2017
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Flammable
- 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 OF
clotrimazole 1% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54633-017 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54633-017-01 29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/05/2017 Labeler - The Podiatree Company (078656000)
