NAILENE ANTIFUNGAL TREATMENT (TOLNAFTATE) LIQUID [PACIFIC WORLD CORPORATION]

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NAILENE ANTIFUNGAL TREATMENT (TOLNAFTATE) LIQUID [PACIFIC WORLD CORPORATION]
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NDC 60193-102-02
Set ID ae22a4f1-77bd-4b37-bf3c-24f402e15bf0
Category HUMAN OTC DRUG LABEL
Packager Pacific World Corporation
Generic Name
Product Class
Product Number
Application Number PART333C
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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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