FDA.reportPublic FDA data

Propylene Glycol

Manufacturer
Radix Laboratories, Inc.
Effective date
2014-12-19
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:39:51

Label at a glance#

ProductPropylene Glycol
Active ingredientPROPYLENE GLYCOL
Label structure7 sections

Dosage and administration

In adult dairy cattle, feed at a rate of 4 fl. oz. (120ml) per head per day, starting 4 days before calving and continuing for 4-6 days.  use as a drench, or mix with feed.

Storage and handling

Store at controlled room temperature between 59 o F to 86 o F (15 o C -30 o C).

Label contents#

Full prescribing information#

• Contents:

OTC - ACTIVE INGREDIENT SECTION

  • Propylene Glycol USP......................100%

INDICATIONS:

INDICATIONS & USAGE SECTION

  • An aid in the prevention and treatment of ketosis in dairy cattle.

Storage:

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature between 59oF to 86oF (15oC -30oC).

Warning:

WARNINGS SECTION

  • SEALED FOR YOUR PROTECTION
  • FOR ANIMAL USE ONLY

Dosage and administration:

DOSAGE & ADMINISTRATION SECTION

  • In adult dairy cattle, feed at a rate of 4 fl. oz. (120ml) per head per day, starting 4 days before calving and continuing for 4-6 days.  use as a drench, or mix with feed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep away from children.

Current Propylene Glycol label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

Item image

SPL UNCLASSIFIED SECTION

PG Gallon JugPG Gallon Jug

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
991861propylene glycol 1 mL/mL Oral SolutionPSN1
991861propylene glycol 1 ML/ML Oral SolutionSCD1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50480-033-40Propylene Glycol3785 mL in 1 BOTTLE, PLASTICLIQUID37851
50480-033-40Propylene Glycol4 in 1 CARTONLIQUID41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50480-033PROPYLENE GLYCOL LIQUID [RADIX LABORATORIES, INC.]12 package rows20141220_e67f4b98-84ed-4e40-a611-ea20ea2f870c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V31
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V31

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50480-03350480-033-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsName fallback
generic name: PROPYLENE GLYCOL
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsName fallback
generic name: PROPYLENE GLYCOL
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsName fallback
generic name: PROPYLENE GLYCOL
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsName fallback
generic name: PROPYLENE GLYCOL
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsName fallback
generic name: PROPYLENE GLYCOL
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsName fallback
generic name: PROPYLENE GLYCOL
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsName fallback
generic name: PROPYLENE GLYCOL
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsName fallback
generic name: PROPYLENE GLYCOL
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsName fallback
generic name: PROPYLENE GLYCOL
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsName fallback
generic name: PROPYLENE GLYCOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.