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.
Updated September 14, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
When using this product
- avoid contact with the eyes
- use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
- contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 133g Can Label
INGREDIENTS AND APPEARANCE
tolnaftate aerosol, powder
Product 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)