TRIPENICOL S- undecylenic acid solution 
Trifluent Pharma LLC

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Tripenicol™ S

DRUG FACTS

ACTIVE INGREDIENT

Undecylenic Acid 25%

PURPOSE

Antifungal

USES

OTHER INFORMATION

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

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 two years of age unless directed by a doctor.

DIRECTIONS

INACTIVE INGREDIENTS

Caprylyl Glycol, Carica papaya (Papaya) Fruit Extract, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Stearate, Hexylene Glycol, Hydroxyethylcellulose, Laureth-4, Origanum vulgare (Oregano) Leaf Oil, PEG-8 Laurate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Purified Water, Sorbitan Laurate, Urea, Vitis vinifera (Grape) Seed Extract.

QUESTIONS OR COMMENTS?

CALL (210) 944-6920

PRINCIPAL DISPLAY PANEL - 37.5 mL Bottle Label

TRIFLUENT
PHARMA®

TRIPENICOL™ S
ANTIFUNGAL SOLUTION

UNDECYLENIC ACID

NDC 73352-550-01

1.25 FL OZ (37.5 mL)

PRINCIPAL DISPLAY PANEL - 37.5 mL Bottle Label
TRIPENICOL S 
undecylenic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73352-550
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID0.25 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
GLYCERIN (UNII: PDC6A3C0OX)  
UREA (UNII: 8W8T17847W)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
PAPAYA SEED OIL (UNII: N4P40Z2DDB)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-4 (UNII: 6HQ855798J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73352-550-0137.5 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: a598f6b3-33d1-468d-a530-6f0c61c08324
Set id: b57500e1-ea6f-4043-99d6-326a7eb57f2f
Version: 1
Effective Time: 20231219
 
Trifluent Pharma LLC