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

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

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 4 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
  • 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 condition persists longer, ask 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 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 - 30 g Tube Carton

Tinactin ®

ANTIFUNGAL

tolnaftate

CREAM

Relieves:

  • itching
  • burning

NET WT

30g (1 oz)

Tinactin 1190

TINACTIN 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69213-1190
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:69213-1190-11 in 1 CARTON09/23/1993
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69213-1190-21 in 1 CARTON09/23/1993
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 - Delpharm Montreal Inc. (203565379)

Revised: 7/2020
Document Id: abab0d8f-a09b-8463-e053-2995a90a9970
Set id: 4e3e319c-f085-734d-e054-00144ff88e88
Version: 9
Effective Time: 20200724
 
Delpharm Montreal Inc.