FDA.reportPublic FDA data

Keto WELL ® Spray

Manufacturer
Pet MD Brands, LLC
Effective date
2023-09-07
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:42:16

Label at a glance#

ProductKetoWELL
Active ingredientCHLORHEXIDINE GLUCONATE, KETOCONAZOLE
Label structure9 sections

Dosage and administration

Spray directly onto affected area(s) up to 3 times daily. Do not allow the animal to lick the area(s) until dry to prevent ingestion.

Storage and handling

Store at controlled room temperature. 

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine Gluconate 2% and Ketoconazole 1%

INDICATIONS & USAGE SECTION

KetoWELL topical spray is formulated with fatty acids and Vitamin E moisturize and hydrate skin. For dogs, cats, and horses. Alcohol-free formula. Good health begins with VetWELL.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Polysorbate 20, Lactic Acid, PEG-75 Lanolin, Sodium Lactate, Aloe Barbadensis (Aloe) Leaf Juice, Fragrance, Methylisothiazolinone.

Directions for Use:

DOSAGE & ADMINISTRATION SECTION

Spray directly onto affected area(s) up to 3 times daily. Do not allow the animal to lick the area(s) until dry to prevent ingestion.

Precautions:

PRECAUTIONS SECTION

For topical use on animals only. Avoid contact with eyes, or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Do not allow the animal to directly inhale the spray. 

Cautions:

WARNINGS SECTION

If undue skin irritation develops or increases, discontinue use and consult a veterinarian. KEEP OUT OF THE REACH OF CHILDREN. Consult your vet before combining with other Chlorhexidine products.

Storage:

STORAGE AND HANDLING SECTION

Store at controlled room temperature. 

SPL UNCLASSIFIED SECTION

Formulated for Dogs, Cats, & Horses

ALCOHOL FREE

Manufactured for:
VetWELL®
Odessa, FL 33556
www.vetwell.com

MFG IN USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

008008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1371365chlorhexidine gluconate 2 % / ketoconazole 1 % Topical SprayPSN3
1371365chlorhexidine gluconate 20 MG/ML / ketoconazole 10 MG/ML Topical SpraySCD3
1371365chlorhexidine gluconate 2 % / ketoconazole 1 % Topical SpraySY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86090-008-08KetoWELL237 mL in 1 BOTTLE, SPRAYSPRAY2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86090-008KETOWELL (CHLORHEXIDINE GLUCONATE, KETOCONAZOLE) SPRAY [PET MD BRANDS, LLC]31 package rows20230910_6dee68e4-91bd-4ee3-ab0a-5fa968203052.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86090-00886090-008-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
KETOCONAZOLER9400W927IACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYSORBATE 207T1F30V5YHIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
PEG-75 LANOLIN09179OX7TBIACT
SODIUM LACTATETU7HW0W0QTIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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.