TRITOLNACIDE C- tolnaftate cream 
Trifluent Pharma LLC

----------

TRITOLNACIDE™ C

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a physician

Ask a physician 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 physician 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.

Directions

Other information

Store at room temperature 20-28°C (68 - 82°F); do not store in extreme heat

Inactive ingredients

Alkyl (C12-15) Benzoate, Butylparaben, Carica Papaya (Papaya) Fruit Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Emulsifying Wax, Ethylparaben, Glycerin, Glycerol Stearate, Hydrogenated Polydecene, Isobutylparaben, Melaleuca Alternifolia (Tea Tree) Oil, Methylparaben, PEG 100 Stearate, Phenoxyethanol, Polyethylene Glycol 400, Propylene Glycol, Propylparaben, Purfied Water, Sodium Polyacrylate, Trideceth-6, Xanthan Gum

Questions/Comments?

(210) 944-6920

PRINCIPAL DISPLAY PANEL - 37 mL Pouch Tube Label

Tear at notch to open. Do not use if seal is broken.

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

TRIFLUENT
PHARMA™

TriTolnacide™ C

TOLNAFTATE

ANTIFUNGAL CREAM
NDC 73352-561-10

1.25 FL. OZ. (37 mL)

PRINCIPAL DISPLAY PANEL - 37 mL Pouch Tube Label
TRITOLNACIDE C 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73352-561
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PAPAYA (UNII: KU94FIY6JB)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHAMOMILE (UNII: FGL3685T2X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73352-561-101 in 1 POUCH06/17/2024
137 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM00506/17/2024
Labeler - Trifluent Pharma LLC (117167281)

Revised: 6/2024
Document Id: ffd7963d-f338-407d-9ec2-b743c921afec
Set id: 12b53c2a-b073-43db-88d9-ede8300626aa
Version: 1
Effective Time: 20240612
 
Trifluent Pharma LLC