TRITOLNACIDE S- tolnaftate solution 
Trifluent Pharma LLC

----------

TriTolnacide™ S

DRUG FACTS

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

USES

WARNINGS

For external use only.

Ask a doctor or pharmacist before use if you are

  • Using any other medicines or cleansers on your skin

When using this product

  • Avoid contact with eyes: rinse immediately with cool tap water if contact occurs.
  • Do not use for vaginal yeast

Stop use and ask a doctor if

  • Irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot or Ringworm) or within 2 weeks (for Jock Itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Do not use on children under 2 years of age unless directed by a doctor.

DIRECTIONS

INACTIVE INGREDIENTS

Butylparaben, butylated hydroxyanisole, butylated hydroxytoluene, Carthamus tinctorius (safflower) seed oil, ethylparaben, isobutylparaben, methylparaben, Origanum vulgare (oregano) leaf oil, phenoxyethanol, propylparaben, Simmondsia chinensis (jojoba) seed oil, tocopherol, white mineral oil.

QUESTIONS OR COMMENTS?

CALL (210) 944-6920

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

PRODUCT SHOULD BE ADMINISTERED UNDER
THE SUPERVISION OF A
LICENSED MEDICAL PRACTITIONER

TRIFLUENT
PHARMA®

TriTolnacide™ S
ANTIFUNGAL SOLUTION

TOLNAFTATE

NDC 73352-560-01
0.5FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label
TRITOLNACIDE S 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73352-560
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
JOJOBA OIL (UNII: 724GKU717M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73352-560-0115 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM00512/11/2023
Labeler - Trifluent Pharma LLC (117167281)

Revised: 12/2023
Document Id: 8370b883-ba80-44ba-845f-98fa9adfb2f3
Set id: b69ba7c9-03c1-4f5e-aa93-3ea1f2db15d8
Version: 1
Effective Time: 20231219
 
Trifluent Pharma LLC