FDA.reportPublic FDA data

Chlorhexidine Gluconate

Manufacturer
Aurora Pharmaceutical, Inc.
Effective date
2025-06-16
Label type
OTC ANIMAL DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 02:44:41

Label at a glance#

ProductChlorhexidine Gluconate
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure9 sections

Dosage and administration

Wet area thoroughly with water. Pour approximately 5 mL of ChlorSeptic 4% and add enough water to make a lather. Lather thoroughly. Rinse thoroughly with clean water.

Storage and handling

Store upright up to 25°C (77°F) with brief excursions to 40°C (104°F). Keep container tightly closed when not in use. Do not freeze.

Label contents#

Full prescribing information#

INDICATIONS

VETERINARY INDICATIONS SECTION

PRO-TEC® ChlorSeptic 4% is a mild scrub containing chlorhexidine gluconate 4% that exhibits bactericidal activity against a wide range of microorganisms.

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

4% chlorhexidine gluconate

DIRECTIONS FOR USE

INSTRUCTIONS FOR USE SECTION

Wet area thoroughly with water. Pour approximately 5 mL of ChlorSeptic 4% and add enough water to make a lather. Lather thoroughly. Rinse thoroughly with clean water.

WARNINGS

WARNINGS SECTION

Avoid contact with eyes and mucous membranes. If in eyes, immediately flush with water for 15 minutes and contact a physician. If swallowed, contact a physician and/or poison control center immediately.

Do not use if allergic or sensitive to the active ingredients.

For veterinary use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

STORAGE

STORAGE AND HANDLING SECTION

Store upright up to 25°C (77°F) with brief excursions to 40°C (104°F).

Keep container tightly closed when not in use. Do not freeze.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Fragrance, isopropyl alcohol, water, dye, aloe vera and other ingredients in a nonalkaline base.

SPL UNCLASSIFIED SECTION

image descriptionimage description

MANUFACTURED IN THE USA

REORDER NO: 59003

MANUFACTURED BY:
Aurora Pharmaceutical, Inc.
NORTHFIELD, MINNESOTA 55057
1-888-215-1256
www.aurorapharmaceutical.com

IN 50-1149  12/2024

PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51072-047-01

PRO-TEC®

ChlorSeptic

4%

with Aloe Vera

Antiseptic Antimicrobial Skin Cleanser

Fast-acting, broad-spectrum antimicrobial skin cleanser

For External Animal Use Only

1 Gallon (3.79 L)

AURORA PHARMACEUTICAL ®

Display Panel 50-1149 1224Display Panel 50-1149 1224

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN11
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD11
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY11
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51072-047-01Chlorhexidine Gluconate3.79 L in 1 BOTTLESOLUTION3.7911
51072-047-01Chlorhexidine Gluconate4 in 1 CARTONSOLUTION411

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8E3
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L3

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51072-04751072-047-01

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
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB

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 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATEPAI Holdings, LLC dba PAI Pharmad3c2d8a7-bad5-410f-af83-e78a45e4b93f2026-08-25Warnings, Adverse reactionsName fallback
brand name: CHLORHEXIDINE GLUCONATE
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEMedline Industries, LP92eddf00-7e23-4d5b-b5cd-38af99ad9e562026-08-19Warnings, Adverse reactionsName fallback
brand name: Chlorhexidine Gluconate
generic name: CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATESage Products LLCbdb6a012-37e5-4664-84a3-134bea2847442026-06-16WarningsName fallback
brand name: CHLORHEXIDINE GLUCONATE
generic name: CHLORHEXIDINE GLUCONATE
Sponge with 4% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd53f4dd22-e4ab-5d8a-e063-6294a90a8c392026-06-11WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Swab Applicator Brushes 4% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXINXIANG XINDA TECHNOLOGY CO.,LTD51c1a74f-c6a8-b831-e063-6294a90a6c712026-05-24WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Swab Stick 2% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXINXIANG XINDA TECHNOLOGY CO.,LTD51c5a926-d137-9119-e063-6294a90a88452026-05-24WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Dyna-Hex 4CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.0a32c299-f7ca-d15c-e063-6294a90af2c12026-04-30WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEMajor Pharmaceuticalsb48e69dc-0913-423f-e053-2a95a90a53df2026-04-29Warnings, Adverse reactionsName fallback
brand name: Chlorhexidine Gluconate
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEBenco Dental21b03b2a-44ee-41c0-e054-00144ff8d46c2026-04-29Warnings, Adverse reactionsName fallback
brand name: Chlorhexidine Gluconate
generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHGCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a6403ad-fa5e-2b4a-e054-00144ff8d46c2026-04-28WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a4cfe-88e0-0a10-e054-00144ff88e882026-04-27Warnings, Adverse reactionsName fallback
brand name: Chlorhexidine Gluconate
generic name: CHLORHEXIDINE GLUCONATE
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a9eda34-d85c-4b66-e054-00144ff88e882026-04-27WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a684f-5f72-347a-e054-00144ff8d46c2026-04-27Warnings, Adverse reactionsName fallback
brand name: Chlorhexidine Gluconate
generic name: CHLORHEXIDINE GLUCONATE
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6cc89ac1-baef-40bb-85a3-d9ae9e3e7a632026-04-27WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEPreferred Pharmaceuticals, Inc.1c3401ef-6a7a-485e-ab7e-52420a36f4e22026-03-27Warnings, Adverse reactionsName fallback
brand name: Chlorhexidine Gluconate
generic name: CHLORHEXIDINE GLUCONATE
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d950be9-9d25-202c-e063-6294a90ada7d2026-03-02Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d9624f6-2a0b-c30f-e063-6294a90ae7172026-03-02Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0b50ef-78e1-5595-e063-6294a90aa84d2026-02-17WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0c6bcd-2242-f734-e063-6294a90a8fbf2026-02-17WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0d7b42-5757-6248-e063-6394a90a94c52026-02-17WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE

Reported adverse events (FAERS/openFDA)#

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