VAMOUSSE LICE DEFENSE (PEDICULICIDE) SHAMPOO [ALLIANCE PHARMA INC.]

VAMOUSSE LICE DEFENSE (PEDICULICIDE) SHAMPOO [ALLIANCE PHARMA INC.]
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NDC 72238-002-01
Set ID 6ac755f6-f615-6c44-e053-2991aa0ade6c
Category HUMAN OTC DRUG LABEL
Packager Alliance Pharma Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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.

    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.

    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.

    • For defense 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.

  • Inactive Ingredients

    Benzyl alcohol, Butyl lactate, Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl myristate, Sodium chloride, Sodium lauryl sulfate, Water

  • Questions?

    1.855.373.7210 or www.VamousseLice.com

    Call to report serious side effects

  • SPL UNCLASSIFIED SECTION

    Pesticide-Free

    LICE DEFENSE

    DAILY SHAMPOO

    KILLS SUPER LICE* BEFORE DETECTED

    VAMOUSSE®

    HOMEOPATHIC

    •  Use 10-14 Days Following Exposure or Treatment

    •  For Use by the Whole Family During:

        - School Outbreaks

        - Summer Camp, Sleepovers

        - Treatment of a Sibling

    •  Made with Eucalyptus

    *as shown in lab studies

    Manufactured For: ALLIANCE

    Alliance Pharma Inc., Cary, NC 27511

    Made in the U.S.A. Vamousse, Alliance and associated devices are trademarks of Alliance Pharmaceuticals Limited

  • Packaging

    image

  • 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)  
    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)  
    PENNYROYAL OIL (UNII: AK85U7Y3MV)  
    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:72238-002-01295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/02/2018
    Labeler - Alliance Pharma Inc. (081138954)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmasol Corporation065144289manufacture(72238-002) , label(72238-002) , pack(72238-002)

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