FDA.reportPublic FDA data

Tripenicol S

Manufacturer
Trifluent Pharma LLC
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:38:58

Label at a glance#

ProductTripenicol S
Active ingredientUNDECYLENIC ACID
Label structure10 sections

Indications and uses

Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis). Relives discomfort, itching, cracking, burning and scaling, which accompany these conditions.

Dosage and administration

Wash the affected area with soap and water and dry thoroughly Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor 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 Supervise children in the use of this product. For Athlete's Foot and Ringworm, use daily ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

PURPOSE

OTC - PURPOSE SECTION

Antifungal

USES

INDICATIONS & USAGE SECTION

  • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis).
  • Relives discomfort, itching, cracking, burning and scaling, which accompany these conditions.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

WARNINGS

WARNINGS SECTION

For external use only

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • Using any other medicines or cleansers on your skin

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area with soap and water and dry thoroughly
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • 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
  • Supervise children in the use of this product.
  • For Athlete's Foot and Ringworm, use daily for 4 weeks; for Jock Itch, use daily for 2 weeks. If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
  • Wash hands after each use.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

CALL (210) 944-6920

PRINCIPAL DISPLAY PANEL - 37.5 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 37.5 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2677081Tripenicol S 25 % Topical SolutionPSN3
998329undecylenic acid 25 % Topical SolutionPSN3
2677081undecylenic acid 250 MG/ML Topical Solution [Tripenicol]SBD3
998329undecylenic acid 250 MG/ML Topical SolutionSCD3
2677081Tripenicol 25 % Topical SolutionSY3
2677081Tripenicol 250 MG/ML Topical SolutionSY3
998329undecylenic acid 25 % Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-550-01Tripenicol S37.5 mL in 1 BOTTLE, WITH APPLICATORSOLUTION37.53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-550-01ML - Milliliter73352-550e88f1875-6be3-44cc-bcaa-775f9dc0a92012024-03-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73352-55073352-550-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
WATER059QF0KO0RIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
GLYCERINPDC6A3C0OXIACT
UREA8W8T17847WIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
OREGANO LEAF OIL7D0CGR40U1IACT
GRAPE SEED OIL930MLC8XGGIACT
PAPAYA SEED OILN4P40Z2DDBIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCOL STEARATE0324G66D0EIACT
PEG-8 LAURATE762O8IWA10IACT
SORBITAN MONOLAURATE6W9PS8B71JIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURETH-46HQ855798JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-20full-release2026-06-01 00:38:28

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tripenicol SUNDECYLENIC ACIDTrifluent Pharma LLCb57500e1-ea6f-4043-99d6-326a7eb57f2f2025-10-14WarningsExact identifier
ndc (package): 73352-550-01
ndc (product): 73352-550
ndc11 (package): 73352055001
spl id: 6a5dd16f-5fbd-4509-af06-5e2c248518e3
spl set id: b57500e1-ea6f-4043-99d6-326a7eb57f2f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.