TINACTIN- tolnaftate aerosol, powder

Tinactin by

Drug Labeling and Warnings

Tinactin by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

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 contents can be harmful or fatal.
• contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

butylated hydroxytoluene, hydroxypropyl cellulose, isobutane,kaolin, magnesium stearate, PPG-12-buteth-16, SD alcohol 40-B (9% w/w), zea mays (corn) starch

Questions?

1-866-360-3266

PRINCIPAL DISPLAY PANEL

TOUGH ACTIN' ®

Tinactin ®

tolnaftate ANTIFUNGAL

Cures and prevents

most athlete's foot

Relieves

• itching
• burning

POWDER SPRAY

goes on dry

talc free

NET WT 133g (4.6 oz)

INGREDIENTS AND APPEARANCE

TINACTIN 
tolnaftate aerosol, powder

Product 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)