Orak-100 Oropharyngeal Antiseptic Solution

Orak-100 by

Drug Labeling and Warnings

Orak-100 by is a Otc medication manufactured, distributed, or labeled by JOAQUIN ARMANDO CARDENAS URQUIDEZ. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAK-100- hydrogen peroxide solution 
JOAQUIN ARMANDO CARDENAS URQUIDEZ

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Orak-100 Oropharyngeal Antiseptic Solution

ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Hypochlorous acid

Sodium hypochlorite

Hydrogen peroxide

INACTIVE INGREDIENTS

WATER

PURPOSE SECTION

PURPOSE

ANTISEPTIC

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.

INDICATIONS AND USAGE

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

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

WARNINGS

Keep in a cool place and away from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

ASK DOCTOR SECTION

In case of accidental ingestion consult your doctor.

STOP USE SECTION

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

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Orak-100 Oropharyngeal Antiseptic Solution

ORAK-100 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81577-6000
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.000005 mL  in 1 mL
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.000015 mg  in 1 mL
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N) SODIUM HYPOCHLORITE0.000004 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.999976 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81577-6000-6240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/10/202111/08/2022
Labeler - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Registrant - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Establishment
NameAddressID/FEIBusiness Operations
JOAQUIN ARMANDO CARDENAS URQUIDEZ951588416manufacture(81577-6000)

Revised: 11/2022
Document Id: ed01fbf7-7a5a-4b94-e053-2995a90a0772
Set id: bd3d5b31-2f80-3717-e053-2995a90a93c3
Version: 2
Effective Time: 20221108