TRIPENICOL S- undecylenic acid solution

Tripenicol S by

Drug Labeling and Warnings

Tripenicol S by is a Otc medication manufactured, distributed, or labeled by Trifluent Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Undecylenic Acid 25%

PURPOSE

Antifungal

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.

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

• 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

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)

INGREDIENTS AND APPEARANCE

TRIPENICOL S 
undecylenic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73352-550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	0.25 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73352-550-01	37.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M005	12/11/2023

Labeler - Trifluent Pharma LLC (117167281)