Label: TOLNAFTATE- athlete foot 2 way spray aerosol, spray
- NDC Code(s): 56104-028-40
- Packager: Premier Brands of America
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 1, 2024
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- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only.
Extremely flammable:
Contents under pressure. Keep away from fire, sparks, and heated surfaces. Do not puncture or incinerate container. Exposure to temperatures above 120°F may cause bursting. Use only as directed. Intentional misuses by deliberately concentrating and inhaling the contents can be harmful or fatal.
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Directions
- shake well before use
- wash affected area and dry thoroughly
- hold can 4-6 inches away from affected area
- spray a thin layer of the product 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
- use daily for 4 weeks for athlete's foot and ringworm
- if condition persists longer, consult a doctor
- this product is not effective on the scalp or nails
- if nozzle clogs, clean with a pin
- Other information
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
TOLNAFTATE
athlete foot 2 way spray aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56104-028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1.3 g in 113 g Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SHEA BUTTER (UNII: K49155WL9Y) SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18) CETRIMONIUM METHOSULFATE (UNII: 277IG2X9QC) SODIUM BICARBONATE (UNII: 8MDF5V39QO) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) PPG-12-BUTETH-16 (UNII: 58CG7042J1) QUATERNIUM-91 (UNII: 00J8H295NB) SORBITYL LAURATE (UNII: 23XPH3M9LR) ISOBUTANE (UNII: BXR49TP611) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56104-028-40 113 g in 1 CANISTER; Type 0: Not a Combination Product 04/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 04/15/2018 Labeler - Premier Brands of America (117557458)