Label: PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE POWDER- tolnaftate powder spray aerosol, spray
- NDC Code(s): 56104-248-01
- Packager: Premier Brands of America 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.
Updated January 25, 2023
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- Active ingredient
For external use only.
Contents under pressure. Avoid Spraying eyes. do not use or store near heat or open flame. Do not puncture or incinerate. Do not store at temperature above 120ºF. Keep out of reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
Stop use and ask a doctor if
- if irritation occurs
- no improvement within 4 weeks for athlete's foot and ringworm
- 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 ringworm, use daily for 4 weeks
- if conditions persist, consult a doctor
- to prevent athlete's foot: wash the feet and dry throughly; spray a thing 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, clean with a pin
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE POWDER
tolnaftate powder spray aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56104-248 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 130 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOBUTANE (UNII: BXR49TP611) KAOLIN (UNII: 24H4NWX5CO) PPG-12-BUTETH-16 (UNII: 58CG7042J1) ALCOHOL (UNII: 3K9958V90M) ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56104-248-01 130 g in 1 CAN; Type 0: Not a Combination Product 03/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/11/2022 Labeler - Premier Brands of America Inc. (117557458)