VAMOUSSE PRO LICE TREATMENT (SODIUM CHLORIDE) LIQUID [TYRA TECH, INC.]

VAMOUSSE PRO LICE TREATMENT (SODIUM CHLORIDE) LIQUID [TYRA TECH, INC.]
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NDC 58962-010-01
Set ID 55d73c20-7ef5-42e9-93f3-73e9b4f5a0ce
Category HUMAN OTC DRUG LABEL
Packager Tyra Tech, Inc.
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Natrum muriaticum 2X (HPUS)

  • Purpose

    Homeopathic pediculicide

  • Uses

    Treats head lice

  • Warnings

    For external use only

    Do not use

    • near eyes
    • inside nose
    • mouth
    • vagina
    • eyebrows or eyelashes.

    See a doctor if lice are present in these areas.

    When using this product:

    • Keep eyes tightly closed and protect eyes with a washcloth or towel.
    • If product gets in eyes, flush with water right away.
    • Scalp itching or redness may occur.

    Stop use and ask a doctor if eye irritation occurs, skin or scalp irritation continues or infection occurs. If pregnant or breastfeeding, ask a health professional before use.

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

  • Directions

    Adults and children 2 years and older.

    • Separate hair into sections, working with 1 inch sections at a time following your normal combing procedure.
    • Thoroughly saturate all hair and scalp as you work, massaging product into the hair generously. To be effective, all lice and nits must come in contact with the product. Note: dilution may reduce efficacy.
    • Use approximately 2 fl oz (2 – 3 pumps) of lotion for an average head of hair.
    • If product needs to be thinned for particular hair type, use a spray bottle to lightly spritz the hair with water, allowing lotion to spread more easily.
    • Using a lice/nit comb, comb hair from as close to the scalp as possible to the end of the hair.
    • If hair dries during combing, apply more product or use a spray bottle to lightly spritz the hair with water, rehydrating the lotion.
    • After combing, thoroughly recheck for lice/nits. Repeat combing if necessary.

    Product may be used as often as needed. Children under 2 years old: ask a doctor.

  • Other Information

    Store between 59-86°F (15 -30°C).

  • Inactive Ingredients

    Benzyl alcohol, Butyl lactate, Cetearyl alcohol, Cetrimonium chloride, DMDM Hydantoin, Fragrance, Isopropyl alcohol, Isopropyl myristate, Magnesium chloride, Magnesium nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Peppermint oil, Triethyl citrate, Water

  • Questions?

    1.855.373.7210 or www.VamousseLice.com

  • PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label

    NDC 58962-010-01

    VAMOUSSE®

    Pro

    • Non-toxic
    • Pesticide-free
    • Facilitates combing for
      lice and nit removal
    • Dehydrates lice AND
      eggs with safe
      ingredients

    FOR LICE TREATMENT
    PROFESSIONALS

    HOMEOPATHIC
    32 FL OZ (946 ML)

    PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    VAMOUSSE PRO LICE TREATMENT 
    sodium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58962-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GERANIOL (UNII: L837108USY)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58962-010-01946 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC09/25/2015
    Labeler - Tyra Tech, Inc. (782845882)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Products, Inc.157469086MANUFACTURE(58962-010) , LABEL(58962-010)

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