VILLIMED ANTIFUNGAL (TOLNAFTATE) LIQUID [EXTREMITY HEALTHCARE INC]

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VILLIMED ANTIFUNGAL (TOLNAFTATE) LIQUID [EXTREMITY HEALTHCARE INC]
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NDC 71129-772-15
Set ID 441b8a31-cdff-6a1b-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Extremity Healthcare Inc
Generic Name
Product Class
Product Number
Application Number PART333C
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  • Drug Facts

  • Active ingredient:

    Tolnaftate 1%

    Purpose

    Antifungal

  • Uses

    • Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • Helps prevent most athlete's foot with daily use
    • For effective relief of itching, burning and cracking
  • Warnings

    • For external use only

    Do not use

    on children under 2 years of age except under the supervision of a doctor

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if:

    • Irritation occurs
    • There is no improvement within 4 weeks

    Keep out of reach of children.

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

  • Directions

    • Wash affected area well, and let product sit for 1-2 minutes before rinsing.
    • Make sure to dry affected area thoroughly.
    • Supervise children in the use of this product
    • For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • Use 1-2 times daily.
    • Use daily for 4 weeks; if condition persists longer, ask a doctor
    • This product is not effective on the scalp or nails 
  • Inactive ingredients:

    Butylhydroxytoluene (BHT), Carthamus Tinctorius (Safflower) Seed Oil, Oryza Sativa (Rice) Bran Oil, Prunus Armenicaca (Apricot) Kernel Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate (Vitamin E).

  • Other Information

    Store between 20° to 30°C (68° to 86°F)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    VILLIMED ANTIFUNGAL 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71129-772
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    APRICOT (UNII: 269CJD5GZ9)  
    SESAME SEED (UNII: 7Y1255HVXR)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71129-772-151 in 1 BOX12/20/2016
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/20/2016
    Labeler - Extremity Healthcare Inc (793823683)
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