Label: TOLNAFTATE- antifungal liquid spray aerosol, spray
- NDC Code(s): 36800-006-53
- Packager: Topco Associates LLC
- 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 February 19, 2021
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- Active ingredient
For external use only.
Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.
- wash affected area and dry thoroughly
- shake can well and spray a thin layer over 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 the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- use daily for 4 weeks
- if conditions persist, consult a doctor
- to prevent athlete's foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
antifungal liquid spray aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1.5 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:36800-006-53 150 g in 1 CAN; Type 0: Not a Combination Product 01/03/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/03/2012 Labeler - Topco Associates LLC (006935977)