Orak-100 Oropharyngeal Antiseptic Solution

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#

ProductOrak-100
Active ingredientHYDROGEN PEROXIDE, HYPOCHLOROUS ACID, SODIUM HYPOCHLORITE
Label structure11 sections

Indications and uses

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

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 INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Hypochlorous acid

Sodium hypochlorite

Hydrogen peroxide

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER

PURPOSE SECTION

OTC - PURPOSE SECTION

PURPOSE

ANTISEPTIC

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

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

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

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

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

WARNINGS

WARNINGS SECTION

Keep in a cool place and away from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

ASK DOCTOR SECTION

OTC - ASK DOCTOR 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 Diabek-100.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orak-100 Oropharyngeal Antiseptic SolutionOrak-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
81577-600081577-6000-6

Ingredients#

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

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

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
ed01fbf7-7a5a-4b94-e053-2995a90a0772bd3d5b31-2f80-3717-e053-2995a90a93c32022-11-08WarningsExact identifier
spl set id: bd3d5b31-2f80-3717-e053-2995a90a93c3

Reported adverse events (FAERS/openFDA)#

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