TINACTIN ANTIFUNGAL- 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 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, cracking, burning, scaling and discomfort

Warnings

For external use only

Flammable:Do not use while smoking or near heat or flame

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.
• do not puncture or incinerate. Contents under pressure. Do not store at temperatures 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 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
• this product is not effective on the scalp or nails
• in case of clogging, clean nozzle with a pin

Other information

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

Inactive Ingredients

Butylated Hydroxytoluene, Fragrance, Isobutane, PPG-12-Buteth-16, SD Alcohol 40-B (10.5% v/v),Talc

Questions?

866-360-3226

PRINCIPAL DISPLAY PANEL - 133 g Can Label

NDC: 11523-4162-1

TOUGH ACTIN' ®

Tinactin ®

ANTIFUNGAL

tolnaftate

Cures and

prevents most

athlete's foot

DEODORANT

POWDER SPRAY

fights odor all day

Relieves itching & burning

NET WT 133g (4.6 oz)

INGREDIENTS AND APPEARANCE

TINACTIN   ANTIFUNGAL
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
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: 11523-4162-1	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)