TOLNAFTATE- tolnaftate athletes foot powder spray spray

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by VALU MERCHANDISERS, CO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most
• athlete’s foot (tinea pedis)
• ringworm (tinea corporis)
• effectively soothes and relieves
• itching
• burning
• cracking
• helps prevent most athlete’s foot from coming back with daily use

Warnings

For external use only

Flammable: Do not use near flame or spark 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
• contents under pressure. Do not puncture or incinerate or store at temperatures above 120°F (49°C).
• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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

• clean the affected area and dry thoroughly
• shake can well before use
• hold can about 6 inches from the area to be treated
• spray a thin layer over the 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 lasts longer, ask a doctor.
• to prevent athlete’s foot, apply to the feet 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 a pin

Inactive ingredients

alcohol SD 40-B, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propane, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

Questions or comments?

1-800-719-9260

Principal Display Panel

Best Choice

Athlete’s Foot

Antifungal

Powder Spray

Tolnaftate 1%

Cures & prevents most athlete’s foot

Relieves itching & burning

NET WT 4.6 OZ (130g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
tolnaftate athletes foot powder spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-555
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.3 g  in 130 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOBUTANE (UNII: BXR49TP611)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)
ALCOHOL (UNII: 3K9958V90M)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63941-555-46	130 g in 1 CAN; Type 0: Not a Combination Product	12/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/12/2017

Labeler - VALU MERCHANDISERS, CO (868703513)