TINACTIN- tolnaftate cream 
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

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

When using this product avoid contact with the eyes

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

ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum

Questions?

1-866-360-3266

Distributed by

Bayer HealthCare LLC, Whippany, NJ, USA, 07981

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Tinactin AF Cream 15g Carton

TOUCH ACTIN'

Tinactin ®

tolnaftate ANTIFUNGAL

CURES AND PREVENTS

MOST ATHLETE'S FOOT

Relieves:

CREAM

NET WT 15G (1/2 OZ)

TINACTIN 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-1190
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
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
Colorwhite (White to Off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-1190-11 in 1 CARTON12/12/2002
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11523-1190-21 in 1 CARTON12/12/2002
230 g in 1 TUBE; Type 0: Not a Combination Product
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: 0553a8f7-cd85-23aa-e063-6394a90ab3c0
Set id: c3b715a9-233a-401a-ba60-f78c1ddf1ded
Version: 12
Effective Time: 20230914
 
Bayer HealthCare LLC.