Label: TRIPENICOL S- undecylenic acid solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • 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)

    PRINCIPAL DISPLAY PANEL - 37.5 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    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)
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