Label: TOLNAFTATE- antifungal powder spray aerosol, powder
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Contains inactivated NDC Code(s)
NDC Code(s): 54633-913-04 - 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 19, 2017
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Flammable:
Do not use near heat or flame, or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
When using this product
- Do not get into eyes or mouth
- 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 the affected area twice daily (morning and night)
- 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
- Use daily for 4 weeks for athletes foot, ringworm; use daily for 2 weeks for jock itch
- If conditions persist, consult a doctor
- To prevent athlete's foot, apply daily (morning and night)
- This product is not effective on the scalps or nails
- In case of clogging, clear nozzle under running water
- Other information
- Inactive ingredient
- Questions or Suggestions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
TOLNAFTATE
antifungal powder spray aerosol, powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54633-913 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOBUTANE (UNII: BXR49TP611) PPG-12-BUTETH-16 (UNII: 58CG7042J1) ALCOHOL (UNII: 3K9958V90M) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54633-913-04 130 g in 1 CANISTER; Type 0: Not a Combination Product 07/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/01/2013 Labeler - The Podiatree Company (078656000)