FDA.reportPublic FDA data

Medicated Antimicrobial

Manufacturer
Nootie, LLC
Effective date
2021-11-11
Label type
OTC ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:41:08

Label at a glance#

ProductMedicated Antimicrobial
Active ingredientCHLORHEXIDINE GLUCONATE, MICONAZOLE NITRATE
Label structure5 sections

Storage and handling

Storage: Store at room temperature (59°F-86°) MADE IN USA

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:                        Purpose
Chlorhexidine Gluconate (2%)           Antibacterial
Miconazole Nitrate (2%)                   Antifungal

INDICATIONS & USAGE SECTION

Uses: For dermatological conditions associated with infections responsive to Miconazole Nitrate and Chlorhexidine Gluconate.

Directions:

Wet coat thoroughly with water. Apply and lather Shampoo over the entire body, allowing 10 minutes of contact time. Rinse completely with water. Do not allow animal to lick while bathing to prevent ingestion. Repeat twice weekly until symptoms subside, then weekly, or as directed by your veterinarian.

GENERAL PRECAUTIONS SECTION

Warnings:

  • For animal use only
  • For topical use on dogs, cats and horses
  • Avoid contact with eyes and mucous membranes
  • If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and immediately consult your veterinarian.

STORAGE AND HANDLING SECTION

Storage: Store at room temperature (59°F-86°)

MADE IN USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nootie

DERMATOLOGY

SOLUTIONS

Medicated

ANTIMICROBIAL SHAMPOO

ANTIFUNGAL AND ANTIBACTERIAL

Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%

FOR DOGS, CATS AND HORSES

 8 fl oz (237ml) / 16 fl  oz ( 474 ml) /  1 Gallon ( 3785 ml)

Nootie
Manufactured for and distributed by
Nootie LLC, 1 SE 4th Ave, Delray Beach, FL 33483
1-800-478-7713 Nootie.com
Product # SAB8 / # SAB16/ # GAB

image descriptionimage description

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116107chlorhexidine gluconate 2 % / miconazole nitrate 2 % Medicated ShampooPSN4
1116107chlorhexidine gluconate 20 MG/ML / miconazole nitrate 20 MG/ML Medicated ShampooSCD4
1116107chlorhexidine gluconate 2 % / miconazole nitrate 2 % Medicated ShampooSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MICONAZOLE 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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51437-203-08Medicated Antimicrobial237 mL in 1 BOTTLE, PLASTICSHAMPOO2374
51437-203-16Medicated Antimicrobial474 mL in 1 BOTTLE, PLASTICSHAMPOO4744
51437-203-28Medicated Antimicrobial3785 mL in 1 BOTTLE, PLASTICSHAMPOO37854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51437-203MEDICATED ANTIMICROBIAL (CHLORHEXIDINE GLUCONATE AND MICONAZOLE NITRATE) SHAMPOO [NOOTIE, LLC]43 package rows20211113_e532bc50-ec38-4264-8dd5-ec7eecd91a54.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51437-20351437-203-16, 51437-203-08, 51437-203-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
MICONAZOLE NITRATEVW4H1CYW1KACTIB

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
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEMedline Industries, LP92eddf00-7e23-4d5b-b5cd-38af99ad9e562026-08-19Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATESage Products LLCbdb6a012-37e5-4664-84a3-134bea2847442026-06-16WarningsName fallback
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
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEBenco Dental21b03b2a-44ee-41c0-e054-00144ff8d46c2026-04-29Warnings, Adverse reactionsName fallback
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
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
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
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.