TOLNAFATE- tolnaftate powder spray aerosol, spray

Tolnafate by

Drug Labeling and Warnings

Tolnafate by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association. 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)
• if used daily, can prevent recurrence of athlete's foot
• relieves sypmtoms of athlete's foot, including itching, burning and cracking

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

When using this product

• do not get into eyes or mouth, if products get into eyes, rinse eyes thoroughly with water
• use only as directed

Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Stop use and ask a doctor if

• irritation occurs
• no improvement within 4 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 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 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 conditions persist, consult a doctorto prevent athlete's foot, apply once or twice daily (morning and/or night)in case of clogging, clear nozzle under running water

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 1-866-964-0939

Principal Display Panel

Quality Choice

Talc- Free

Athlete's

Foot Relief

Antifungal Powder Spray

Tolnaftate 1%

• Cures Most Athlete's Foot and Prevents Reccurences
• Relieves Itching, Cracking, and Burning

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: 63868-181
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: 63868-181-46	130 g in 1 CAN; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/19/2017

Labeler - Chain Drug Marketing Association (011920774)