Label: WOODWARDS MYCOCIDE CLINICAL NS- tolnaftate liquid

  • 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 October 20, 2014

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

    Purpose

    Antifungal

  • Uses

    • Cures most fungal skin infections, including athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • Effectively relieves itching, burning, cracking and scaling accompanying such conditions
  • Warnings

    For external use only.

    Do not use

    • near the mouth or eyes
    • with known sensitivities to any listed ingredients
    • on children under 2 years of age unless directed by a doctor

    When using this product avoid eye contact. If accidental eye contact occurs, rinse thoroughly with water for 10-15 minutes.

    Stop use and ask a doctor if rash or irritation occurs, or if no improvement is seen after four weeks.

    If pregnant/breast-feeding, consult a health professional before using.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Clean affected area with soap and warm water and dry thoroughly
    • Apply a thin layer two times a day (mornings and evenings) to affected area especially the space between and around toes
    • For athlete's foot, use daily for four weeks or as directed by a physician
    • Allow solution to soak into skin or rub in to dry more quickly before putting on socks
    • This product is not effective on scalp or nails.
    • Following a proper foot hygiene regimen along with wearing well fitting, ventilated shoes and clean socks that are changed at least daily is helpful in preventing future infections
  • Other information

    You may report questions or adverse reaction from using this product to 1(541)-476-3178, 8 am to 5 pm (M–F), PST.

  • Inactive ingredients

    Water (Aqua), Caprylic/Capric Triglycerides, Isopropyl Palmitate, Polyquaternium 37, Propylene Glycol, Dicaprylate Dicaprate, PPG-1 Trideceth-6, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Phemerol Chloride, Cetrimonium Chloride, Allantoin, Didecyldimonium Chloride, Quaternium-15.

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    MAXIMUM STRENGTH

    UNHEALTHY
    HEALTHY

    DOCTOR
    FORMULATED

    WOODWARD'S
    MYCOCIDE    ®
    CLINICAL NS

    ANTIFUNGAL
    TREATMENT

    Kills Fungus Around
    Finger and Toe Areas

    Includes:
    2 Extra-Coarse Nail Grinders
    NET WT 1 FL OZ (30 mL) Antifungal Liquid

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    WOODWARDS MYCOCIDE CLINICAL NS 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60193-100
    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)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60193-100-021 in 1 CARTON
    130 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
    2NDC:60193-100-041 in 1 CARTON
    239 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
    3NDC:60193-100-061 in 1 CARTON
    37.4 mL in 1 TUBE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C04/24/2013
    Labeler - Pacific World Corporation (089693097)
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