TINACTIN- tolnaftate aerosol, spray 
Bayer HealthCare 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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Tinactin ®

Drug Facts

Active ingredient

Tolnaftate 1 %

Purpose

Antifungal

Uses

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

Do not use on children under 2 years of age unless directed by a doctor.

When using this product

  • Avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

butylated hydroxytoluene, isobutane, PPG-12-buteth-16, SD alcohol 40-B (29% v/v)

Questions?

1-866-360-3266

PRINCIPAL DISPLAY PANEL - 150g Can Label

TOUGH ACTIN'



Tinactin
®

ANTIFUNGAL



tolnaftate

Cures and



prevents most



athlete's foot

LIQUID SPRAY



cools the burn

Relieves itching & burning

NET WT 150g (5.3 oz)

Liquid spray label

TINACTIN 
tolnaftate aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0165
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ISOBUTANE (UNII: BXR49TP611)  
PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0165-3150 g in 1 CAN; Type 0: Not a Combination Product09/23/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/23/1993
Labeler - Bayer HealthCare LLC (112117283)

Revised: 9/2023
Document Id: 0553ddb3-f760-21bf-e063-6294a90ad700
Set id: bb878f31-2189-4427-aacf-5bce96d75978
Version: 9
Effective Time: 20230914
 
Bayer HealthCare LLC