Label: TINACTIN ANTIFUNGAL- tolnaftate aerosol, powder
- NDC Code(s): 11523-4162-1
- 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 ingredients
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
When using this product
- avoid contact with the eyes
- use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
- contents under pressure. do not puncture or incinerate. Do not store at temperatures above 120°F.
- wash the 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
- PRINCIPAL DISPLAY PANEL - 133 g Can Label
INGREDIENTS AND APPEARANCE
tolnaftate aerosol, powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-4162 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 ISOBUTANE (UNII: BXR49TP611) PPG-12-BUTETH-16 (UNII: 58CG7042J1) TALC (UNII: 7SEV7J4R1U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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:11523-4162-1 133 g in 1 CAN; Type 0: Not a Combination Product 02/28/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/28/2014 Labeler - Bayer HealthCare LLC. (112117283)