TINACTIN- tolnaftate cream 
Delpharm Montreal 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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Tinactin ®

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • cures most jock itch (tinea cruris)
  • for effective relief of itching, chafing and burning

Warnings

For external use only

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

Do not use on children under 2 years of age except under the advice and supervision of 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
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 2 weeks; if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

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 07981

PRINCIPAL DISPLAY PANEL - 15g Tube Carton

Tinactin®

tolnaftate

ANTIFUNGAL

CREAM

Relieves:

  • itching
  • burning
  • chafing

NET WT

15g (1/2 oz)

Tinactin 0934

TINACTIN 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69213-0934
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:69213-0934-21 in 1 CARTON09/23/1993
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 - Delpharm Montreal Inc. (203565379)

Revised: 7/2020
Document Id: abab2e6e-5832-5362-e053-2995a90a95c3
Set id: 4e3e6450-3692-043a-e054-00144ff88e88
Version: 9
Effective Time: 20200724
 
Delpharm Montreal Inc.