PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE POWDER- tolnaftate powder spray aerosol, spray

Premier Solutions Antifungal Tolnaftate Powder by

Drug Labeling and Warnings

Premier Solutions Antifungal Tolnaftate Powder 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

• proven clinically effective in the treatment of most athelete's foot (tinea pedis) and ringworm (tinea corporis)
• prevents the recurrence of most athelete's foot with daily use
• for effective relief of itching, cracking and burning

Warnings

For external use only.

Flammable:

Contents under pressure. Avoid Spraying eyes. do not use or store near heat or open flame. Do not puncture or incinerate. Do not store at temperature above 120ºF. Keep out of reach of children. Use only as directed. 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

• if irritation occurs
• no improvement within 4 weeks for athlete's foot and ringworm

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
• for athlete's foot and ringworm, use daily for 4 weeks
• if conditions persist, consult a doctor
• to prevent athlete's foot: wash the feet and dry throughly; spray a thing layer of the product to the feet once or twice daily (morning and/or night)
• 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 1-866-964-0939

Principal Display Panel

Meijer

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

PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE POWDER 
tolnaftate powder spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-248
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: 56104-248-01	130 g in 1 CAN; Type 0: Not a Combination Product	03/11/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/11/2022

Labeler - Premier Brands of America Inc. (063849780)