Label: TINACTIN- tolnaftate aerosol, powder
- NDC Code(s): 11523-0139-1
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 20, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking
Do not use on children under 2 years of age unless directed by a doctor.
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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)
- 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 condition persists longer, ask 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
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TINACTIN
tolnaftate aerosol, powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0139 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) ISOBUTANE (UNII: BXR49TP611) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PPG-12-BUTETH-16 (UNII: 58CG7042J1) KAOLIN (UNII: 24H4NWX5CO) MAGNESIUM STEARATE (UNII: 70097M6I30) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) Product Characteristics Color white (White to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-0139-1 133 g in 1 CAN; Type 0: Not a Combination Product 11/29/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 11/29/2023 Labeler - Bayer HealthCare LLC. (112117283)