Label: TINACTIN- tolnaftate aerosol, powder
- NDC Code(s): 11523-0072-5
- Packager: Bayer HealthCare 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.
Drug Label Information
Updated December 1, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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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
- use daily for 2 weeks; if condition persists longer, ask a doctor
- this product is not effective on the scalp or nails
- in case of clogging, clean nozzle with a pin
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 133g Can Label
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INGREDIENTS AND APPEARANCE
TINACTIN
tolnaftate aerosol, powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0072 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOBUTANE (UNII: BXR49TP611) PPG-12-BUTETH-16 (UNII: 58CG7042J1) TALC (UNII: 7SEV7J4R1U) 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:11523-0072-5 133 g in 1 CAN; Type 0: Not a Combination Product 09/23/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/23/1993 Labeler - Bayer HealthCare LLC (112117283)