Animal NDC 54420-027-01 Propylene Glycol

Animal Product Information

Field Name Field Value
Animal NDC Code 54420-027-01
Proprietary Name Propylene Glycol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Propylene Glycol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Gilmer Industries, Inc.
Product Type Otc Animal Drug
Usage Information
    This product is used as For use as an aid in the prevention and treatment of Ketosis (Acetonemia) in dairy cattle.Repackaged from USP/EP Grade NPE-freeFDA Acceptance: CFR 21, Part 582.1666—Animal Drugs, Feeds and Related ProductsThis substance is generally recognized as safe (except in cat food) when used in accordance with good manufacturing or feeding practice.
Active Ingredient(s)
  • Propylene Glycol
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Propylene Glycol Images

Propylene Glycol Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - 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.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.