Label: NAILENE ANTIFUNGAL TREATMENT- 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 17, 2014

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  • SPL UNCLASSIFIED SECTION

    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.

  • SPL UNCLASSIFIED SECTION

    Imported & Distributed by:

    UK/R.-U.: Pacific World Ltd.,
    Stoke-on-Trent, Staffordshire. ST4 2 PJ
    Australia: Creative Brands PTY LTD
    30 Bando Road, Springvale, VIC 3171
    South Africa: Indigo Cosmetics, Cape Town, 7460
    New Zealand: BDM Grange, Auckland

  • PRINCIPAL DISPLAY PANEL - 18 mL Bottle Carton

    new

    61100

    nailene®

    DOCTOR
    FORMULATED

    MAXIMUM STRENGTH
    ANTIFUNGAL
    TREATMENT

    Powered by
    MYCOCIDE®

    For finger and
    toe areas

    No need to remove
    nail polish or acrylics

    INCLUDES:

    2 Extra-Coarse Nail Grinders

    NET WT .6 FL OZ (18 mL) Antifungal Liquid

    Principal Display Panel - 18 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NAILENE ANTIFUNGAL TREATMENT 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60193-102
    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:60193-102-021 in 1 CARTON
    118 mL in 1 BOTTLE, 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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