Other
Drug Facts
Tinactin Aerosol, Powder
FDA Label NDC 11523-0137
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Tinactin (NDC 11523-0137). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
(To Deliver) Tolnaftate 1%
Purpose
Antifungal
Uses
- proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
- helps prevent most athlete's foot with daily use
- for effective relief of itching, burning and cracking
Warnings
For external use only
Otc - Do Not Use
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.
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 4 weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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
- store between 20° to 25°C (68° to 77° F)
Inactive Ingredients
butylated Hydroxytoluene, fragrance, hydroxypropyl cellulose, isobutane, kaolin, magnesium stearate, PPG-12-Buteth-16, SD Alcohol 40-B (9% v/v),zea mays (corn) starch
Questions?
1-866-360-3266 or visit us at www.tinactin.com
Principal Display Panel - 133 G Can Label
TOUGH ACTIN'
®
Tinactin
®
tolnaftate
ANTIFUNGAL
CURES AND PREVENTS
MOST ATHLETE'S FOOT
Relieves:
- Itching
- Burning
DEODORANT
POWDER SPRAY
Fights Odor
Talc Free
NET WT 133g (4.6 oz)
* Please review the disclaimer below.
