TOLNAFTATE- tolnaftate powder spray talc free aerosol, spray

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America Inc.. 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

Premier

Antifungal

Athlete's Foot Powder Spray

Tolnaftate 1%

• Cures most athlete's foot
• Relieves itching & burning
• Talc Free

NET WT 4.6 OZ (130g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
tolnaftate powder spray talc free aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-036
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)
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)
ALCOHOL (UNII: 3K9958V90M)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)
KAOLIN (UNII: 24H4NWX5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-036-46	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 - Premier Brands of America Inc. (080051232)