Label: VAMOUSSE PRO TOTAL LICE EMERGENCY KIT- pediculicide kit

  • 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 July 13, 2023

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

  • ACTIVE INGREDIENT

    Vamousse Lice Treatment:

    Natrum Muriaticum 2X (HPUS)

    Vamousse Lice Defense Daily Shampoo:

    Eucalyptus globulus 2X (HPUS)

    Natrum Muriaticum 2X (HPUS)

  • PURPOSE

    Purpose

    Pediculicide

  • INDICATIONS & USAGE

    Vamousse Lice Treatment:

    Treats head lice infestation

    Vamousse Lice Defense Daily Shampoo:

    For daily defense against head lice infestations

  • WARNINGS

    For external use only

    Vamouss Lice Treatment:

    Do Not Use near eyes, inside nose, mouth, or vagina, on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

    Vamousse Lice Defense Daily Shampoo:

    Do not use near eyes, inside nose or mouth, on eyebrows or eyelashes. See a doctor if lice are present in these areas. Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

    Vamousse Lice Treatment
    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.
    Do not puncture or incinerate, contents under pressure.
    Do not smoke or use near open flame or heated surface.
    Consider using gloves to apply the product if you have sensitive skin as prolonged contact may dry your skin.

    Vamousse Lice Defense Daily Shampoo:

    When using this product Do not use near the eyes. Close eyes while applying.

    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 continues or infection occurs.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • 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.

  • DOSAGE & ADMINISTRATION

    Vamousse Lice Treatment:

    Directions

    Important: Read ALL instructions on pamphlet inside box.

    Do not use on pets or to treat pubic or body lice.

    Adults and children 2 years and older:

    Treat to kill lice and eggs (nits):

    • Start with DRY hair
    • Separate hair into 3-4 sections with clips.
    • Shake can well.
    • Part a section of hair into a 1-inch section, focus the nozzle tip on the scalp and apply a generous amount of mousse along the length of the hair
    • Pay special attention to nape of the neck and behind the ears
    • Saturate all hair and scalp, massaging the mousse to break down the foam, thoroughly soaking the hair. To be effective all lice and nits must be contacted. Depending on the length of hair, the full can may be needed.
    • Repeat process until all sections of hair are saturated and wait 15 minutes.

    Remove lice and eggs (nits):

    • Although dead, nits remain attached to the hair.
    • After 15-minute treatment, use enclosed comb, to remove dead lice and nits from the wet hair.
    • Working with a 1-inch section of hair, insert the comb against the scalp, and pull through to the end, wiping on a disposable paper towel after each stroke.
    • If hair dries, apply more product to ease combing.
    • Repeat combing if necessary
    • Shampoo and towel dry hair.

    Vamousse may be repeated as needed. Children under 2 years: ask a doctor.

    Vamousse Lice Defense Daily Shampoo:

    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 defense against 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 SAFETY INFORMATION

  • INACTIVE INGREDIENT

    Vamousse Lice Treatment

    Inactive Ingredients

    Ammonium benzoate, Benzyl alcohol, Butyl lactate, Cocomidopropyl betaine, Fragrance, Isopropyl alcohol, Isopropyl myristate, Propellant A-46, Sodium lauryl sulfate, Triethyl citrate, Water

    Vamousse Lice Defense Daily Shampoo:

    Inactive Ingredients

    Benzyl alcohol, Butyl lactate, Cocomidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl myristate, Sodium Chloride, Sodium lauryl sulfate, Water

  • QUESTIONS

    Questions? 1.855.373.7210 or www.VamousseLice.com. Call to report serious side effects.

  • PRINCIPAL DISPLAY PANEL

    Packaging Artwork

  • INGREDIENTS AND APPEARANCE
    VAMOUSSE PRO TOTAL LICE EMERGENCY KIT 
    pediculicide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72238-005
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72238-005-011 in 1 BOX; Type 0: Not a Combination Product05/10/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE, WITH APPLICATOR 177 mL
    Part 1 of 2
    VAMOUSSE LICE DEFENSE 
    eucalyptus globulus, natrum muriaticum shampoo
    Product Information
    Item Code (Source)NDC:72238-004
    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 CHLORIDE2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)  
    GERANIOL (UNII: L837108USY)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYL LACTATE (UNII: 0UI63W814U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/01/2021
    Part 2 of 2
    VAMOUSSE LICE TREATMENT 
    pediculicide aerosol, foam
    Product Information
    Item Code (Source)NDC:72238-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    BUTYL LACTATE (UNII: 0UI63W814U)  
    GERANIOL (UNII: L837108USY)  
    LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)  
    AMMONIUM BENZOATE (UNII: AC80WD7GPF)  
    VANILLIN (UNII: CHI530446X)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1177 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/10/2023
    Labeler - Alliance Pharma Inc. (081138954)