tripenicol™ s

tripenicol™ s
SPL v3
SPL
SPL Set ID b57500e1-ea6f-4043-99d6-326a7eb57f2f
Route
topical
Published
Effective Date 2023-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
undecylenic acid (0.25 g)
Inactive Ingredients
water hydroxyethyl cellulose, unspecified glycerin urea propylene glycol oregano leaf oil grape seed oil papaya seed oil cetyl alcohol glycol stearate peg-8 laurate sorbitan monolaurate polysorbate 20 glyceryl monostearate laureth-4 phenoxyethanol caprylyl glycol ethylhexylglycerin hexylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-12-11

Purpose

Antifungal

Description

DRUG FACTS


Medication Information

Warnings

For external use only

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.
Purpose

Antifungal

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.
Other Information

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

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.

Description

DRUG FACTS

Section 42229-5

DRUG FACTS

Section 50565-1

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.
Active Ingredient

Undecylenic Acid 25%

Questions Or Comments?

CALL (210) 944-6920

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)
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)

Ask A Doctor Or Pharmacist Before Use If You Are
  • Using any other medicines or cleansers on your skin

Structured Label Content

Warnings (WARNINGS)

For external use only

Uses (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.
Purpose (PURPOSE)

Antifungal

Directions (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.
Other Information (OTHER INFORMATION)

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

Inactive Ingredients (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.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

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.
Active Ingredient (ACTIVE INGREDIENT)

Undecylenic Acid 25%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

CALL (210) 944-6920

When Using This Product (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 (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)
Principal Display Panel 37.5 Ml Bottle Label (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)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • Using any other medicines or cleansers on your skin

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)