PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE POWDER- tolnaftate powder spray aerosol, spray
Premier Brands of America Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Premier Solutions Tolnaftate Powder Spray - Talc Free

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)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.3 g in 130 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56104-248-01	130 g in 1 CAN; Type 0: Not a Combination Product	03/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	03/11/2022

Labeler - Premier Brands of America Inc. (117557458)

Revised: 6/2022

Document Id: e22282c0-7a7b-666d-e053-2995a90a3b8f

Set id: e2228302-3596-0526-e053-2a95a90a8882

Version: 1

Effective Time: 20220623

Premier Brands of America Inc.