VAMOUSSE LICE PREVENTION (SODIUM CHLORIDE) SHAMPOO [TYRATECH, INC.]

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VAMOUSSE LICE PREVENTION (SODIUM CHLORIDE) SHAMPOO [TYRATECH, INC.]
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NDC 58962-003-01
Set ID fe4b3e9b-5267-4c9c-ab9d-b18d70c96481
Category HUMAN OTC DRUG LABEL
Packager TyraTech, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • Drug Facts

  • Active Ingredient

    Natrum muriaticum 1X (Sodium chloride, USP)

  • Purpose

    Pediculosis remedy and prophylactic

  • Uses

    For the prevention of head lice infestations

  • Warnings

    For external use only

    • Ask a doctor before use if you have infestation of eyebrows or eyelashes, or if you are pregnant.

    • 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 skin irritation or infection is present or develops.

    • Keep out of reach of children.

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

    Stop use and ask a doctor if eye irritation occurs, skin or scalp irritation continues or infection occurs – Children under 6 months: ask a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Important: Read Warnings before use. Adults and children 6 months and over:

    • Apply a generous amount of shampoo to wet hair, work into a lather and massage into scalp. Rinse thoroughly.
    • Repeat process and leave shampoo on hair for at least 3 minutes.
    • To treat head lice infestation, use the shampoo daily for at least 2 weeks.
    • For best results on an extreme head lice infestation, use Vamousse treatment before using shampoo.

    Product may be used as often as needed.

  • Other Information

    Store between 59-86°F (15-30°C)

  • Inactive Ingredients

    Benzyl alcohol, Cocomidopropyl betaine, Caprylic / capric triglycerides, Coconut oil, Disodium EDTA, Fragrances, Purified Water, Sodium laureth sulfate, Tea tree oil.

  • Questions?

    1.855.373.7210 or www.VamousseLice.com

  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    TYRATECH
    5151 McCrimmon Parkway, Suite 275
    Morrisville, NC 27560

  • PRINCIPAL DISPLAY PANEL - 236 ML Bottle Carton

    DAILY SHAMPOO APPLICATION

    NDC 58962-003-01
    HOMEOPATHIC

    PREVENTS
    LICE INFESTATION
    IN 1 EASY STEP!
     

    • HELPS KEEP YOUR FAMILY LICE FREE
    • NON-TOXIC

    VAMOUSSE™

    LICE PREVENTION
    SCIENTIFICALLY PROVEN SAFE & EFFECTIVE

    8 FL OZ (236 ML)
    GENTLE FOR DAILY USE

    PRINCIPAL DISPLAY PANEL - 236 ML Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VAMOUSSE LICE PREVENTION 
    sodium chloride shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58962-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37, chloride ion - UNII:Q32ZN48698) SODIUM CHLORIDE1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GERANIOL (UNII: L837108USY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58962-003-011 in 1 CARTON
    1236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/16/2014
    Labeler - TyraTech, Inc. (782845882)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Products, Inc.157469086MANUFACTURE(58962-003) , LABEL(58962-003)
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