FRAXINUS AMERICANA (FRAXINUS AMERICANA BARK) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]

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FRAXINUS AMERICANA (FRAXINUS AMERICANA BARK) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]
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NDC 68428-394-03, 68428-394-05, 68428-394-06, 68428-394-11, 68428-394-12
Set ID 7c6d95a6-a4f8-4f79-bdf8-03bb27dea35a
Category HUMAN OTC DRUG LABEL
Packager Washington Homeopathic Products
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENTS

    FRAX AMER

  • USES

    To relieve the symptoms of cramps in feet.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of reach of children.

  • INDICATIONS

    Indications:

    FRAX AMER   Cramps in feet

  • STOP USE AND ASK DOCTOR

    If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

  • DIRECTIONS

    Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.  Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

  • INACTIVE INGREDIENTS

    Sucrose/Lactose

  • PRINCIPAL DISPLAY PANEL

    The OTC potency range of FRAX AMER is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM.

    Availability is subject to change.

    Label

    All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled.

    ‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice.

    Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce.

  • INGREDIENTS AND APPEARANCE
    FRAXINUS AMERICANA 
    fraxinus americana bark pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68428-394
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FRAXINUS AMERICANA BARK (UNII: 0B24UR1O1S) (FRAXINUS AMERICANA BARK - UNII:0B24UR1O1S) FRAXINUS AMERICANA BARK30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68428-394-0375 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2010
    2NDC:68428-394-05150 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2010
    3NDC:68428-394-11300 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2010
    4NDC:68428-394-12600 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2010
    5NDC:68428-394-061200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/03/2010
    Labeler - Washington Homeopathic Products (084929389)
    Registrant - Washington Homeopathic Products (084929389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washington Homeopathic Products084929389manufacture(68428-394)
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