TOLNAFTATE- foot odor control spray powder aerosol, powder

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 doctor
• to 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

disteardimonium hectorite, fragrance, isobutane, isopropyl myristate, SD alcohol 40-B, sodium bicarbonate

Questions?

call 1-866-964-0939

Principal Display Panel

Premier

Foot & Sneaker

Antifungal Powder Spray

• Cures most athlete's foot and recurrences
• Reduces odors
• Tolnaftate 1%

with baking soda

NET WT 4 OZ (113g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
foot odor control spray powder aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-008
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 113 g

Inactive Ingredients
Ingredient Name	Strength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALCOHOL (UNII: 3K9958V90M)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-008-04	113 g in 1 CANISTER; Type 0: Not a Combination Product	01/01/2013

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

Labeler - Premier Brands of America Inc. (080051232)