VITE20 (MICONAZOLE NITRATE) LIQUID [BLAINE LABS INC.]

VITE20 (MICONAZOLE NITRATE) LIQUID [BLAINE LABS INC.]
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NDC 63347-810-01
Set ID 28a8d0dd-aab9-44ff-bab6-7ec4b5036a71
Category HUMAN OTC DRUG LABEL
Packager Blaine Labs Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • DRUG FACTSActive Ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Keep out of reach of children.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • INDICATIONS

    • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis)
    • Relieves Itching, cracking, burning and scaling.  which accompany these conditions
    • Prevents most Athlete's Foot with daily use
  • WARNINGS

    • For external use only
    • Do not use :
    •    On children under two (2) years of age unless directed by a physician
    • In or near the mouth or the eyes
    • For vaginal yeast infections
  • When using this product

    avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

  • Stop use and consult a physician

    if irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch)

  • DIRECTIONS

    • Was the affected area with soap and water, dry thorougly, then apply sparingly over the affected area. Use twice daily (morning and night) or as directed by a physician
    • Supervise children in the use of this product
    • For Athlete's Foot and Ringworm, use daily for four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician
    • Wash hands after each use.
  • Other Information

    • Store at room temperature
  • INACTIVE INGREDIENTS

    Isopropyl Alcohol, Deionized Water, Triethanokamine, Glycerin, Hydroxypropylcelluose, Tocopheryl Acetate, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben, Phenoxyethanol

  • Vite20 product label

    VITÉ 20

    BRUSH - ON

    NDC# 63347-810-01

    Vité20®

    BRUSH-ON

    KILLS FUNGUS

    Maxium Strength

    Professional Formula

    15 mL (0.5 FL OZ)

    SEE SIDE PANEL FOR MORE INFORMATION

    KILLS FUNGUS

    *Made in the U.S.A.

    Questions or Comments?

    Call 800-307-8818 M-F

    7:00 am - 5:00 pm PST

    www.vite20.com

    Manufactured by:

    Blaine Labs, Inc.

    11037 Lockport Place

    Santa Fe Springs, CA 90670

    Please recycle!

    This package is made from recyclable materials

    06100-p-bx01

    Vite20 - 810

    res

  • INGREDIENTS AND APPEARANCE
    VITE20 
    miconazole nitrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE0.30 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63347-810-011 in 1 BOX04/01/2016
    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 finalpart333C04/01/2016
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture(63347-810)

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