HAMAMELIS VIRGINIANA PELLET [HOMEOLAB USA INC.]

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HAMAMELIS VIRGINIANA PELLET [HOMEOLAB USA INC.]
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NDC 60512-1021-1
Set ID 4ed53493-d1f5-4791-81cd-cc3ab9360bbd
Category HUMAN OTC DRUG LABEL
Packager HOMEOLAB USA INC.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT HPUS

    HAMAMELIS VIRGINIANA 1X & UP

    Witch Hazel

  • PURPOSE

    HEMORRHOIDS*

  • USE

    For self-limiting condition listed above or as directed by a health professional.

  • WARNINGS

    Do not use if pellet-dispenser seal is broken.

    Stop use and ask a doctor if symptoms persist more than 3 days or worsen.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • DIRECTIONS

    Adults: Allow 3 or 4 pellets to dissolve in the mouth 3 times a day until symptoms are relieved or as directed by a health professional.

  • OTHER INFORMATION

    Store at room temperature.

  • INACTIVE INGREDIENTS

    Lactose, sucrose.

  • REFERENCES

    The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

  • DESCRIPTION

    80 Pellets

    Pellet dispenser

    Mfd for: HOMEOLAB USA

    3025 De L'Assomption, Montreal, QC, H1N 2H2, CANADA

    1-800-404-4666 / www.homeolab.com

    Product of Canada

  • LABEL

    IMAGE OF TUBE LABEL

  • INGREDIENTS AND APPEARANCE
    HAMAMELIS VIRGINIANA 
    hamamelis virginiana pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-1021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-1021-180 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/18/2013
    Labeler - HOMEOLAB USA INC. (202032533)
    Registrant - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(60512-1021)
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