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 ® Jock Itch

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 2 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 - 15g Tube Carton

Tinactin JI 15 g Carton

TOUCH ACTIN'

Tinactin®
tolnaftate ANTIFUNGAL

CURES MOST JOCK ITCH

ANTIFUNGAL

CREAM

Relieves:

NET WT
15g (1/2 oz)

TINACTIN 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0934
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:11523-0934-21 in 1 CARTON12/12/2002
115 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: 0553c22b-8963-ee3c-e063-6394a90a34c0
Set id: 0a80a5b0-3216-46f6-8801-7066ef59aee4
Version: 11
Effective Time: 20230914
 
Bayer HealthCare LLC.