TOLNAFTATE- antifungal powder spray aerosol, powder

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by The Podiatree Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

​ ​Purpose

Antifungal

Uses

• Cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
• If used daily, can prevent recurrence of athlete's foot
• Relieves symptoms of athlete's foot, including itching, burning, and cracking

​Warnings

For external use only.

Flammable:

Do not use near heat or flame, or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

​When using this product

• Do not get into eyes or mouth
• Use only as directed
• Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

​Stop use and ask a doctor if

• irritation occurs
• no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

​Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

​Directions

• Wash affected area and dry thoroughly
• Shake can well and 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• Use daily for 4 weeks for athletes foot, ringworm; use daily for 2 weeks for jock itch
• If conditions persist, consult a doctor
• To prevent athlete's foot, apply daily (morning and night)
• This product is not effective on the scalps or nails
• In case of clogging, clear nozzle under running water

​Other information

Store between 20º and 30ºC (68ºF and 86ºF)

Inactive ingredient

BHT, isobutane (propellent), PPG-12-buteth-16, SD alcohol 40-B (14%w/w), talc

Questions or Suggestions?

1.855.763.8733 or www.thepodiatreecompany.com. Our commitment to you is 100%

satisfaction. If you are not completely satisf ied, please contact us directly for a full refund.

Principal Display Panel

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
antifungal powder spray aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54633-913
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 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: 54633-913-04	130 g in 1 CANISTER; Type 0: Not a Combination Product	07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/01/2013

Labeler - The Podiatree Company (078656000)