Label: VAMOUSSE LICE PROTECTION- eucalyptus globulus leaf and sodium chloride shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 30, 2015

If you are a consumer or patient please visit this version.

  • 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)