FDA.reportPublic FDA data

diabek-100 Oropharyngeal Antiseptic Solution

Manufacturer
JOAQUIN ARMANDO CARDENAS URQUIDEZ
Effective date
2021-03-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:49:15

Label at a glance#

Productdiabek-100
Active ingredientHYPOCHLOROUS ACID, SODIUM HYPOCHLORITE, HYDROGEN PEROXIDE
Label structure10 sections

Indications and uses

Gargle: Gargle 2 or 3 times with Diabek-100 for 30 seconds and then spit, it is not necessary to rinse with water. Perform this procedure 2 or 3 times a day for as long as indicated by your doctor

Dosage and administration

Rinse mouth with Diabek-100 for 1 minute and then spit, it is not necessary to rinse with water. Before using Diabek-100 oropharyngeal antiseptic, wash and rinse your mouth then place 15 ml of Diabek-100 in your mouth and rinse or gargle.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS Hypochlorous acid

ASK A DOCTOR

OTC - ASK DOCTOR SECTION

In case of accidental ingestion consult your doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER

KEEP OUT OF REACHO OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

PURPOSE

OTC - PURPOSE SECTION

PURPOSE ANTISEPTIC

WARNINGS AND PRECAUTIONS SECTION

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

WARNINGS

WARNINGS SECTION

CHILDREN UNDER 9 YEARS OF AGE MUST BE SUPERVISED BY AN ADULT.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Rinse mouth with Diabek-100 for 1 minute and then spit, it is not necessary to rinse with water.

Before using Diabek-100 oropharyngeal antiseptic, wash and rinse your mouth then place 15 ml of Diabek-100 in your mouth and rinse or gargle.

INDICATIONS AND USAGE SECTION

INDICATIONS & USAGE SECTION

Gargle: Gargle 2 or 3 times with Diabek-100 for 30 seconds and then spit, it is not necessary to rinse with water.

Perform this procedure 2 or 3 times a day for as long as indicated by your doctor

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

diabek-100 Oropharyngeal Antiseptic Solutiondiabek-100 Oropharyngeal Antiseptic Solution

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
81577-100081577-1000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPOCHLOROUS ACID712K4CDC10ACTIB
WATER059QF0KO0RIACT
SODIUM HYPOCHLORITEDY38VHM5ODACTIB
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
ed022232-ae42-a080-e053-2995a90a987abc90fa7f-ae1f-e5b2-e053-2995a90ad3002022-11-08WarningsExact identifier
spl set id: bc90fa7f-ae1f-e5b2-e053-2995a90ad300

Reported adverse events (FAERS/openFDA)#

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