Label: BOUMATIC SYST X PREMIUM- glycerin liquid

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 30, 2021

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  • Precautions & Hazards

    NOT FOR HUMAN USE
    FOR EXTERNAL USE ONLY
    FOR MANUFACTURING USE ONLY

  • General Storage

    Store in a closed container away from sources of heat. If product becomes frozen, thaw and mix well before use.

  • Use Directions

    Consult your BouMatic representative
    for specific use instructions and
    recommended dispensing equipment.

  • BouMatic Syst X Premium

    BouMatic Syst X Premium

    BouMatic Syst X Premium

  • INGREDIENTS AND APPEARANCE
    BOUMATIC SYST X PREMIUM 
    glycerin liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:48106-2037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2) 20 g  in 100 g
    PEG-75 LANOLIN (UNII: 09179OX7TB) 20 g  in 100 g
    water (UNII: 059QF0KO0R) 10 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48106-2037-14529 g in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/03/2021
    Labeler - BOUMATIC, LLC (124727400)
    Establishment
    NameAddressID/FEIBusiness Operations
    BOUMATIC, LLC124727400api manufacture
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