Label: TOLCYLEN ANTIFUNGAL SOLUTION- tolnaftate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 1, 2022

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  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Warnings

    Keep out of reach of children

  • Uses

    Cures most Athlete’s Foot (Tinea Pedis) ■ Relieves itching, cracking, burning and scaling, which accompanies this condition ■
    Prevents recurrence of Athlete’s Foot

  • Warnings

    Do not use on children under 2 years of age ■ For external use only ■ Avoid contact with the eyes. If eye contact occurs, wash thoroughly with
    water ■ Stop use and consult a physician if irritation occurs or if there is no improvement within four (4) weeks ■ Keep out of reach of children ■ If swallowed,
    get medical help or contact a poison control center right away ■ If pregnant or breast-feeding, ask a health-care professional before use.

  • Directions

    Wash the affected area with soap and water.
    ■ Dry thoroughly, then apply a thin layer over the affected area.
    ■ Use twice daily (morning and night) or as directed by a physician.
    ■ Pay special attention to the spaces between the toes and the areas around the edges and under the front of the nails.
    ■ Wear well-fitted ventilated shoes and change socks at least once daily.
    ■ Use daily for four (4) weeks. If condition persists longer, consult a physician.
    ■ Wash hands after each use. Store and use at room temperature.

  • Inactive Ingredeints

    Inactive Ingredients: Ethyl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol, Water
    Cosmetic Ingredients: Urea, Lactic Acid, Jojoba Oil, Undecylenic Acid, Dimethyl Isosorbide, Vitamin E

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    TOLCYLEN ANTIFUNGAL SOLUTION 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70945-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    UREA (UNII: 8W8T17847W)  
    UNDECYLENIC ACID (UNII: K3D86KJ24N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Product Characteristics
    Coloryellow (Clear Fluid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70945-100-751 in 1 CARTON12/16/2016
    17.5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/16/2016
    Labeler - Marlinz Pharma, LLC (080251509)