VAMOUSSE LICE PROTECTION (EUCALYPTUS GLOBULUS LEAF AND SODIUM CHLORIDE) SHAMPOO [TYRATECH, INC.]

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VAMOUSSE LICE PROTECTION (EUCALYPTUS GLOBULUS LEAF AND SODIUM CHLORIDE) SHAMPOO [TYRATECH, INC.]
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NDC 58962-004-01
Set ID 084e1f03-3ce0-4663-b98b-74516ee9fc43
Category HUMAN OTC DRUG LABEL
Packager TyraTech, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients:Purpose:
    Eucalyptus globulus 2X (HPUS)Head lice preventer
    Natrum muriaticum 2X (HPUS)Pediculicide
  • Uses

    For protection against head lice infestations.

  • Warnings

    For external use only.

    Do not use

    • near eyes
    • inside nose or mouth
    • on eyebrows or eyelashes. See a doctor if lice are present in these areas.

    When using this product:

    • Do not use in or near the eyes. Close eyes while product is being applied.
    • Do not permit contact with mucous membranes, such as inside the nose, as irritation or stinging may occur.

    Stop use and ask a doctor

    • if eye irritation occurs
    • skin or scalp irritation or infection occurs.

    Keep out of reach of children. If pregnant or breast-feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years and older:

    • Apply a generous amount of shampoo to wet hair, work into a lather and massage into scalp. Leave shampoo in hair for at least 3 minutes. Rinse.
    • For protection against a head lice infestation, use daily for at least 10 to 14 days to kill any lice that may have hatched.
    • For an active head lice infestation, use Vamousse® Lice Treatment before using this shampoo.

    Children under 2 years: ask a doctor.

    Product may be used as often as needed.

  • Other Information

    Store between 59-86°F (15 -30°C).

  • Inactive Ingredients

    Benzyl alcohol, Butyl lactate, Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl myristate, Magnesium lauryl sulfate, Sodium chloride, Water

  • Questions?

    1.855.373.7210 or www.VamousseLice.com

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    GENTLE DAILY SHAMPOO

    NDC 58962-004-01
    PESTICIDE-FREE

    100% EFFECTIVE*
    PROTECTION
    AGAINST HEAD LICE

    VAMOUSSE®

    • KILLS LICE BEFORE YOU
      KNOW THEY ARE THERE
    • HELPS KEEP YOUR
      FAMILY LICE FREE
    • SAFE, NON-TOXIC

    LICE
    PROTECTION

    SATISFACTION
    100%
    GUARANTEED

    8 FL OZ (236 ML)
    HOMEOPATHIC

    19160FRT2014338

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    VAMOUSSE LICE PROTECTION 
    eucalyptus globulus leaf and sodium chloride shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58962-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYL LACTATE (UNII: 0UI63W814U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GERANIOL (UNII: L837108USY)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MAGNESIUM LAURYL SULFATE (UNII: T88HA2N17X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58962-004-011 in 1 CARTON
    1236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/29/2016
    Labeler - TyraTech, Inc. (782845882)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Products, Inc.157469086MANUFACTURE(58962-004) , LABEL(58962-004)
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