TOLNAFATE- tolnaftate powder spray aerosol, spray

Tolnafate by

Drug Labeling and Warnings

Tolnafate by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) and jock itch (tinea cruris)
• can prevent recurrence of most athlete's foot
• relieves sypmtoms of athlete's foot, including itching, burning, cracking, and chafing associated with jock itch

WARNINGS

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

• avoid contact with the eyes or mouth
• use only as directed

Stop use and ask a doctor if

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

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) or as directed by a doctor
• supervise children in the use of this product
• to prevent athlete's foot, apply once or twice daily (morning and/or night)
• 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 for athlete's foot and ringworm; use daily for 2 weeks for jock itch
• if condition persists, consult a doctor
• this product is not effective on the scalp or nails
• if nozzle clogs, clean with a pin

Other information

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

Inactive ingredients

BHT, isobutane, kaolin, PPG-12-Buteth-16, SD alcohol 40-B, zea mays (corn) starch

Questions?

Call 1-888-423-0139

Principal Display Panel

TopCare health

MEDICATED

Athlete's Foot

Powder Spray

TOLNAFTATE 1% ANTIFUNGAL

• Cures Most Athlete's Foot & Prevents Recurrences
• Relieves Itching, Cracking & Burning
• Talc-Free

NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

TOLNAFATE 
tolnaftate powder spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-876
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)
KAOLIN (UNII: 24H4NWX5CO)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)
ALCOHOL (UNII: 3K9958V90M)
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-876-46	130 g in 1 CAN; Type 0: Not a Combination Product	05/22/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/22/2017

Labeler - Topco Associates LLC (006935977)