Antifungal Liquid Spray

Antifungal Liquid Spray

Drug Labeling and Warnings

Drug Details

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TOLNAFTATE- antifungal liquid spray aerosol, spray 
Topco Associates LLC

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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Antifungal Liquid Spray

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

​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

  • avoid contact with the eyes or mouth
  • use only as directed

Stop use and ask a doctor if

  • irritation occurs
  • no improvement within 4 weeks

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)
  • 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)
  • this product is not effective on the scalp or nails

​Other information

store between 20º and 30ºC (68ºF and 86º)

​Inactive ingredients

BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B(36%w/w)

Questions?

call 1-888-423-0139

​Principal Display Panel

TopCare

Medicated
Antifungal Liquid Spray
Tolnaftate 1%

  • Cures most athlete's foot
  • Relief from burning and itching

Net WT 5.3 OZ (150g)

Top Care_Antifungal Tolnaftate Liquid Spray_50-021TC.jpg

Top Care_Antifungal Tolnaftate Liquid Spray_50-021TC.jpg

TOLNAFTATE 
antifungal liquid spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 36800-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.5 g  in 150 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ISOBUTANE (UNII: BXR49TP611)  
PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 36800-006-53150 g in 1 CAN; Type 0: Not a Combination Product01/03/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/03/2012
Labeler - Topco Associates LLC (006935977)

Revised: 12/2017
 
Topco Associates LLC


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