TINACTIN- tolnaftate aerosol, powder
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Tinactin ®

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

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
in case of clogging, clean nozzle with 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

TOUGH ACTIN' ®

Tinactin®

tolnaftate ANTIFUNGAL

Cures and prevents

most athlete's foot

Relieves itching

& burning

POWDER SPRAY

goes on dry

NET WT 133g (4.6 oz)

Tinactin AF Powder Spray

TINACTIN
tolnaftate aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-0777
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOBUTANE (UNII: BXR49TP611)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white (White to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-0777-2	133 g in 1 CAN; Type 0: Not a Combination Product	09/23/1993

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	09/23/1993

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2023

Document Id: 0553bb25-3831-042c-e063-6394a90a17ef

Set id: 00a17e61-0d91-41e0-9cbe-c7c0b3093f3c

Version: 10

Effective Time: 20230914

Bayer HealthCare LLC.