DIABEK-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.

----------

diabek-100 Oropharyngeal Antiseptic Solution

ACTIVE INGREDIENTS

ACTIVE INGREDIENTS Hypochlorous acid

ASK A DOCTOR

In case of accidental ingestion consult your doctor.

INACTIVE INGREDIENTS

WATER

KEEP OUT OF REACHO OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

PURPOSE

PURPOSE ANTISEPTIC

WARNINGS AND PRECAUTIONS SECTION

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

WARNINGS

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

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.

INDICATIONS AND 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

diabek-100 Oropharyngeal Antiseptic Solution

DIABEK-100 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81577-1000
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.000005 mL  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:81577-1000-1240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/02/202111/08/2022
Labeler - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Registrant - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Establishment
NameAddressID/FEIBusiness Operations
JOAQUIN ARMANDO CARDENAS URQUIDEZ951588416manufacture(81577-1000)

Revised: 11/2022
Document Id: ed022232-ae42-a080-e053-2995a90a987a
Set id: bc90fa7f-ae1f-e5b2-e053-2995a90ad300
Version: 2
Effective Time: 20221108
 
JOAQUIN ARMANDO CARDENAS URQUIDEZ