TOLNAFTATE- antifungal powder spray aerosol, powder

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services Inc.. 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)
• can prevent recurrence of most athlete's foot
• relieves symptoms 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 cans be harmful or fatal.

When using this product

• do not get into eyes or mouth
• use only as directed

Stop use and ask a doctor if

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

Do not use

on children under 2 years of age unless directed by a doctor.

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
• 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 athletes foot, ringworm and for jock itch use daily for 2 weeks
• if conditions persist, consult a doctor
• to prevent athlete's foot, apply daily once or twice daily (morning and/or 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?

Call 1-866-964-0939

Principal Display Panel

Family Wellness

Antifungal

Powder Spray

Tolnaftate 1%

Cures and Prevents Most Athlete's Foot

Relieves Itching and Burning

NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
antifungal powder spray aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-065
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: 55319-065-30	130 g in 1 CANISTER; Type 0: Not a Combination Product	01/10/2013	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/10/2013	05/18/2020

Labeler - Family Dollar Services Inc. (024472631)