Label: TRITOLNACIDE S- tolnaftate 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

    Tolnaftate 1%

  • PURPOSE

    Antifungal

  • USES

    • Treats most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis)
    • Relieves discomfort, irritation, cracking, scaly skin between the toes and itching, burning feet.
  • 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 2 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 the 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

    Butylparaben, butylated hydroxyanisole, butylated hydroxytoluene, Carthamus tinctorius (safflower) seed oil, ethylparaben, isobutylparaben, methylparaben, Origanum vulgare (oregano) leaf oil, phenoxyethanol, propylparaben, Simmondsia chinensis (jojoba) seed oil, tocopherol, white mineral oil.

  • QUESTIONS OR COMMENTS?

    CALL (210) 944-6920

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

    PRODUCT SHOULD BE ADMINISTERED UNDER
    THE SUPERVISION OF A
    LICENSED MEDICAL PRACTITIONER

    TRIFLUENT
    PHARMA®

    TriTolnacide™ S
    ANTIFUNGAL SOLUTION

    TOLNAFTATE

    NDC 73352-560-01
    0.5FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TRITOLNACIDE S 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73352-560
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73352-560-0115 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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