TINACTIN ANTIFUNGAL- tolnaftate aerosol, powder 
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 ® Antifungal

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

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

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

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
  • shake can well and spray 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
  • in case of clogging, clean nozzle with a pin

Other information

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

Inactive ingredients

alcohol denat. (11% v/v), butylated hydroxytoluene, corn starch/acrylamide/sodium acrylate copolymer, fragrance, isobutane, PPG-12-buteth-16, talc

Questions?

1-866-360-3266

Distributed by
MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA,
a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 133g Can Label

NDC 11523-4161-2

TOUGH ACTIN' ®
Tinactin®

ANTIFUNGAL
tolnaftate

Cures and
prevents most
athlete's foot

DEODORANT
POWDER SPRAY

fights odor all day

Relieves itching & burning

NET WT 133g (4.6 oz)

PRINCIPAL DISPLAY PANEL - 133g Can Label
TINACTIN  ANTIFUNGAL
tolnaftate aerosol, powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4161
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)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorwhite (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-4161-2133 g in 1 CAN; Type 0: Not a Combination Product10/01/201105/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/01/201105/01/2016
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 5/2019
Document Id: 88ef26bb-c758-4be3-e053-2995a90aa631
Set id: ec83cef5-d8ea-4df1-aa2a-08c25040b32c
Version: 4
Effective Time: 20190515
 
Bayer HealthCare LLC.