Label: FORTINIA- clotrimazole 1% solution
- NDC Code(s): 54633-214-01
- 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.
Updated December 20, 2017
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- Active Ingredient
- Do not use
- Stop use and ask a doctor or pharmacist if
- KEEP OUT OF REACH OF CHILDREN.
• 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
clotrimazole 1% solution
Product 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)