Label: TOLNAFTATE- antifungal spray liquid aerosol, spray
- NDC Code(s): 81522-078-01
- Packager: FSA Store Inc.
- 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 May 8, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Flammable:
Contents under pressure. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate container.Do not store at temperature above 120ºF. Keep out fo reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
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Directions
- wash affected area and dry thoroughly
- shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- 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 daily
- for athlete's foot and ring worm, use daily for 4 weeks
- if condition persists, consult a doctor
- to prevent athlete's foot: wash the feet and dry thoroughly; spray a thin layer of the product to the feet once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
- if nozzle clogs, clear with a pin
- Other information
- Inactive ingredients
- Questions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
TOLNAFTATE
antifungal spray liquid aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81522-078 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 0.15 g in 150 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOBUTANE (UNII: BXR49TP611) PPG-12-BUTETH-16 (UNII: 58CG7042J1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81522-078-01 150 g in 1 CAN; Type 0: Not a Combination Product 05/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 05/08/2023 Labeler - FSA Store Inc. (049283340)