Label: PROPYLENE GLYCOL liquid

  • NDC Code(s): 54420-027-01, 54420-027-05
  • Packager: Gilmer Industries, Inc.
  • 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 August 4, 2021

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  • PURPOSE

    For use as an aid in the prevention and treatment of Ketosis (Acetonemia) in dairy cattle.

    Repackaged from USP/EP Grade 

    NPE-free

    FDA Acceptance: CFR 21, Part 582.1666—Animal Drugs, Feeds and Related Products

    This substance is generally recognized as safe (except in cat food) when used in accordance with good manufacturing or feeding practice.

  • USER SAFETY WARNINGS

    Animal Use Only

    Keep Out of Reach of Children

    WARNING
    Causes eye irritation

    • Wear chemical splash goggles.

    • If skin contact causes irritation, wear impervious gloves, a synthetic apron and other protective equipment to prevent contact.

    • Wash hands thoroughly after handling, before eating or before smoking.

    • Do NOT eat, drink, or smoke in work areas.

    • Keep container tightly closed when not in use.

    • Store in a cool, dry, well-ventilated area.

    • Do NOT store with poisonous or ill-smelling items.

    FIRST AID

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
    If eye irritation persists: Get medical advice.

    IF ON SKIN: Wash with soap and water. Wash clothing before reuse.

    IF INHALED: Remove to fresh air.

    IF SWALLOWED: Drink plenty of water. Contact a physician.

  • DOSAGE & ADMINISTRATION

    Directions

    Dose at the rate of 4 oz. orally of Propylene Glycol per head twice daily as a drench for 4-6 weeks.

  • Drug Facts

    :Label:Label

  • INGREDIENTS AND APPEARANCE
    PROPYLENE GLYCOL 
    propylene glycol liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54420-027
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.00103698 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54420-027-013.78 L in 1 JUG
    2NDC:54420-027-05207.9 L in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/04/2021
    Labeler - Gilmer Industries, Inc. (066017575)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gilmer Industries, Inc.066017575api manufacture, manufacture, label, pack
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