Label: VAMOUSSE LICE DEFENSE- pediculicide 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 June 28, 2023

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

  • DRUG FACTS-Active Ingredients

    Eucalyptus globulus 2X (HPUS)

    Natrum muriaticum 2X (HPUS)

  • Purpose

    Pediculicide

  • Uses

    For daily defense against head lice infestations.

  • Warnings

    For external use only.

  • Warnings

    Do not use • near eyes • inside nose, mouth, or vagina

    • 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.

  • Warnings

    When using this product:

    • Do not use in or 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.

  • Warnings

    Stop use and ask a doctor • if eye irritation occurs

    • skin or scalp irritation or infection occurs.

  • Warnings

    If pregnant or breast-feeding, ask a health

    professional before use.

  • Children's Warning

    Keep out of reach of children. If swallowed, get

    medical help or contact a Poison Control Center right away.

  • Directions

    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.

    • Use daily for at least 10 - 14 days following treatment, during risk of re-infestation.

    • 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.

  • Inactive Ingredients

    Inactive Ingredients Benzyl alcohol, Butyl lactate,

    Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl

    myristate, Sodium chloride, Sodium lauryl s sulfate, Water

  • Questions?

    Questions? 1.855.373.7210 or www.VamousseLice.com

    Call to report serious side effects

  • Additionl Label Content

    Vamousse, Alliance and associated devices are trade

    marks of Alliance Pharmaceuticals Limited

    Manufactured For:

    Alliance Pharma Inc., Cary, NC 27511

  • VAMOUSSE LICE DEFENSE SHAMPOO 118 ML Bottle

    SUPER LICE DEFENSE

    NDC 72238-002-02

    DAILY DEFENSE AGAINST LICE

    LICE DEFENSE

    VAMOUSSE®

    HOMEOPATHIC

    GENTLE SHAMPOO

    Kills Lice*

    for treatment follow-up

    Safe, Non-Toxic

    when used as directed

    Pesticide-Free

    *as shown in lab studies

    4 FL OZ (118 ml)

    Drug Facts

    Active Ingredients Purpose

    Eucalyptus globulus 2X (HPUS) Pediculicide

    Natrum muriaticum 2X (HPUS) Pediculicide

    Uses: For daily defense against head lice infestations.

    Warnings

    For external use only.

    Do not use • near eyes • inside nose, mouth, or vagina

    • 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.

    When using this product

    • Do not use in or 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 or infection occurs.

    If pregnant or breast-feeding, 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:

    • 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.

    • Use daily for at least 10 - 14 days following treatment, during risk of re-infestation.

    • 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.

    Inactive Ingredients Benzyl alcohol, Butyl lactate,

    Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl

    myristate, Sodium chloride, Sodium lauryl s sulfate, Water

    Questions? 1.855.373.7210 or www.VamousseLice.com

    Call to report serious side effects

    Vamousse, Alliance and associated devices are trade

    marks of Alliance Pharmaceuticals Limited

    Manufactured For:

    Alliance Pharma Inc., Cary, NC 27511

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  • INGREDIENTS AND APPEARANCE
    VAMOUSSE LICE DEFENSE 
    pediculicide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72238-002
    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) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    MENTHYL ACETATE, (-)- (UNII: W8C5F4H1OA)  
    OCTYL ACETATE (UNII: X0FN2J413S)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PENNYROYAL OIL (UNII: AK85U7Y3MV)  
    CARVONE, (-)- (UNII: 5TO7X34D3D)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    MENTHONE, (+/-)- (UNII: 9NH5J4V8FN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CITRAL (UNII: T7EU0O9VPP)  
    LEMON OIL (UNII: I9GRO824LL)  
    GERANYL ACETATE (UNII: 3W81YG7P9R)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    WATER (UNII: 059QF0KO0R)  
    DECANAL (UNII: 31Z90Q7KQJ)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    LINALYL ACETATE, (+)- (UNII: 3ID3M89AV9)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    BUTYL LACTATE (UNII: 0UI63W814U)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    .ALPHA.-TERPINEOL (UNII: 21334LVV8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72238-002-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/21/2019
    Labeler - Alliance Pharma Inc. (081138954)
    Establishment
    NameAddressID/FEIBusiness Operations
    PLZ Corp118914032manufacture(72238-002) , label(72238-002) , pack(72238-002)