TINACTIN- tolnaftate aerosol, spray

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 while smoking or near heat or flame

Avoid contact with the eyes

When using this product

• 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

Do not use on children under 2 years of age unless directed by a doctor.

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

alcohol denat. (29% v/v), butylated hydroxytoluene, isobutane, PPG-12-buteth-16

Questions?

1-866-360-3266

PRINCIPAL DISPLAY PANEL - 150g Can Label

NDC: 11523-0165-3

TOUGH ACTIN'

Tinactin ®

ANTIFUNGAL

tolnaftate

Cures and

prevents most

athlete's foot

LIQUID SPRAY

cools the burn

Relieves itching & burning

NET WT 150g (5.3 oz)

INGREDIENTS AND APPEARANCE

TINACTIN 
tolnaftate aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0165
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0165-3	150 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)