FDA.reportPublic FDA data

k-100 antiseptic and disinfectant gel

Manufacturer
JOAQUIN ARMANDO CARDENAS URQUIDEZ
Effective date
2021-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:49:15

Label at a glance#

ProductK-100
Active ingredientSODIUM HYPOCHLORITE, HYPOCHLOROUS ACID, HYDROGEN PEROXIDE
Label structure10 sections

Indications and uses

Wash your hands with soap and water and apply K-100 Gel

Dosage and administration

Antiseptic: Clean the wound with neutral soap and apply directly (or diluted according to medical indications) on the wound, repeat the process 3 times a day or as indicated by your doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS SECTION

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Hypochlorous acid

Sodium hypochlorite

Hydrogen peroxide

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Carbomer 940

Water

Triethanolamine

PURPOSE SECTION

OTC - PURPOSE SECTION

PURPOSE

ANTISEPTIC

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Antiseptic: Clean the wound with neutral soap and apply directly (or diluted according to medical indications) on the wound, repeat the process 3 times a day or as indicated by your doctor.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Wash your hands with soap and water and apply K-100 Gel

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Keep in a cool place and away from direct sunlight.

Store at room temperature away from direct sunlight

WARNINGS

WARNINGS SECTION

In case of accidental ingestion consult your doctor

STOP USE SECTION

OTC - STOP USE SECTION

Discontinue use in case of irritation, local discomfort, or hypersensitivity to the components of k-100.GEL.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

k-100 antiseptic and disinfectant gelk-100 antiseptic and disinfectant gel

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81577-500081577-5000-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE CAPROYL GLUTAMATE0F2FO57253IACT
SODIUM HYPOCHLORITEDY38VHM5ODACTIB
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
HYPOCHLOROUS ACID712K4CDC10ACTIB
HYDROGEN PEROXIDEBBX060AN9VACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ee3d2643-7adf-50df-e053-2a95a90ad070bd3cc2a6-e481-7a05-e053-2995a90a1f552022-11-24WarningsExact identifier
spl set id: bd3cc2a6-e481-7a05-e053-2995a90a1f55

Reported adverse events (FAERS/openFDA)#

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