Label: CONAZOL ANTIFUNGAL- tolnaftate solution/ drops

  • 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 January 27, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Tolnaftate 1%

  • Purposes

    Antifungal

  • Uses

    For effective treatment of athlete's foot, jock itch and ringworm. Not for relief of infected finger nails and toe nails or effective against bacteria or viruses.

  • Warnings

    For external use only

    • Avoid contact with eyes.
    • Do not use on children under 2 years of age unless directed by a doctor.

    Stop and ask a doctor if

    • If treating athlete's foot and ringworm: If irritation occurs or if there is no improvement within 4 weeks.
    • If treating jock itch: If irritation occurs or if there is no improvement within 2 weeks.

    Keep out of the reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    Clean or wash the affected area 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. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change socks at least once daily. For athlete's foot and ringworm use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

  • Other Information

    • Store at room temperature 15°-30°C (59°-86°F)
  • QUESTIONS

    • Questions or comments, call (800) 428-9489
  • Inactive Ingredients

    Purified water, PEG-8, Cetearyl alcohol and Ceteth-20 phosphate and decetyl phosphate, Propylene glycol, Cocamidopropyl betaine, Octoxynol-9, Glyceryl stearate, Stearyl alcohol, Hydroxyethyl cellulose, Imidazolidinyl urea, Cetyl alcohol, Methylparaben, Propylparaben, Triethanolamine,Citric acid

  • SPL UNCLASSIFIED SECTION

    Distributed by: MarcasUSA, LLC
    El Segundo CA, 90245

  • PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

    NOTHING MORE EFFECTIVE

    Conazol®
    ANTIFUNGAL

    TOE FUNGUS
    ELIMINATOR
    with Tolnaftate 1%

    Cures &
    Prevents
    Fungus

    1 FL OZ (30 ML)

    Principal Display Panel 30 mL Carton
  • INGREDIENTS AND APPEARANCE
    CONAZOL  ANTIFUNGAL
    tolnaftate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75940-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    propylene glycol (UNII: 6DC9Q167V3)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    octoxynol-9 (UNII: 7JPC6Y25QS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Stearyl alcohol (UNII: 2KR89I4H1Y)  
    HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) (UNII: 7Q6P4JN1QT)  
    IMIDUREA (UNII: M629807ATL)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    methylparaben (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75940-126-011 in 1 CARTON10/29/2017
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/29/2017
    Labeler - MarcusUSA (016139820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Private Label Partners046033481LABEL(75940-126)
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