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

• cures most jock itch
• for effective relief of itching, chafing and burning

Warnings

For external use only

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

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 2 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
• use daily for 2 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

alcohol denat. (11% v/v), butylated hydroxytoluene, isobutane, PPG-12-buteth-16, talc

Questions?

1-866-360-3266

PRINCIPAL DISPLAY PANEL - 133g Can Label

NDC: 11523-0072-5

TOUGH ACTIN' ®

Tinactin®

ANTIFUNGAL

tolnaftate

Cures most

jock itch

POWDER SPRAY

goes on dry

Relieves itching,

burning & chafing

NET WT 133g (4.6 oz)

INGREDIENTS AND APPEARANCE

TINACTIN 
tolnaftate aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0072
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: 11523-0072-5	133 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)