Premier Brands Antifungal Powder 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]

TOLNAFTATE- antifungal powder spray aerosol, powder 
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 Brands Antifungal Powder Spray

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.

​When using this product

  • do not get into eyes or mouth
  • 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 for athlete's foot, ringworm and 2 weeks for jock itch

​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) 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 86º)

​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

Premier

Medicated

Antifungal

Powder Spray

Tolnaftate 1%

  • Cures and prevents most athletes foot
  • Relieves itching and burning

NET WT 4.6 FL OZ (130g)

PREMIER_Antifungal Powder Tolnaftate Spray_APTSLP-3-01.jpg

TOLNAFTATE 
antifungal powder spray aerosol, powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 56104-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.3 g  in 130 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ISOBUTANE (UNII: BXR49TP611)  
PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
ALCOHOL (UNII: 3K9958V90M)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 56104-002-46130 g in 1 CANISTER; Type 0: Not a Combination Product01/01/201302/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201302/22/2020
Labeler - Premier Brands of America Inc. (080051232)

Revised: 12/2019
 
Premier Brands of America Inc.