Premier Tolnaftate 1% Anti-Fungal

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOLNAFTATE- antifungal liquid maximum strength liquid 
Premier Brands of America, Inc.

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Premier Tolnaftate 1% Anti-Fungal

​Active ingredient

Tolnaftate 1% w/w

​Purpose

Antifungal

Uses

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

Warnings

For external use only.

Do not use

on children under 2 years of age unless directed by a doctor.

When using this product

avoid contact with eyes.

Stop use and consult a doctor if

  • irritation occurs
  • there is no improvement in 4 weeks

Keep out of reach of children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

​Directions

Read all warnings and directions. Use only as directed.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between toes
  • wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor
  • to prevent athlete's foot: wash the feet thoroughly, apply a thin layer of the product to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

​Other information​

  • store at room temperature 15°-30°C (59° - 86°F)
  • protect from freezing. If freezing occurs warm to room temperature
  • keep tightly closed when not in use

​Inactive ingredient

Water, Acrylates Copolymer, Glycerin (RSPO), Phenoxyethanol, Tocopherol, Sodium Hydroxide, Ethylhexyglycerin

Questions?

Call 1-866-964-0939

Principal Display Panel

Premier

MAXIMUM

STRENGTH

ANTIFUNGAL

LIQUID

Tolnaftate 1%

Proven clinically

effective in the cure

& prevention of

fungus on fingers,

toes & around nails

Relieves itching,

burning & scaling

With moisturizer

Built-in brush for

easy appplication

NET WT 1 FL OZ (30 mL)

nail solution 1

nail solution 2

TOLNAFTATE 
antifungal liquid maximum strength liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 56104-242
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.3 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 56104-242-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product03/05/202106/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/05/202106/30/2025
Labeler - Premier Brands of America, Inc. (063849780)

Revised: 12/2024
Document Id: 29b6f122-71f3-b3f3-e063-6394a90a6327
Set id: bcbd52e4-696e-df39-e053-2a95a90a83f8
Version: 5
Effective Time: 20241220