DIABEK-100- hydrogen peroxide gel
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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diabek-100 antiseptic gel

ACTIVE INGREDIENTS

Hypochlorous acid

Sodium hypochlorite

INACTIVE INGREDIENTS

CARBOMER 940

WATER

TRIETHANOLAMINE

DOSAGE AND ADMINISTRATION

Clean the wound with soap and water, apply Diabek-100 antiseptic solution on the wound 3 times a day or as directed by a doctor. If the wound requires covering, place a wet or dry sterile dressing with antiseptic solution as directed by your doctor.

INDICATIONS AND USAGE

Super oxidation antiseptic Gel

Does not irritate, does not generate bacterial resistance, for long-term use.

Assists in the healing of:

Diabetic foot wounds

Varicose ulcers

Skin lesions

Broad spectrum, effective against fungi, viruses and bacteria.

PURPOSE SECTION

PURPOSE ANTISEPTIC

ASK A DOCTOR

Discontinue use in case of hypersensitivity to the components of Diabek-100.

KEEP OUT OF REACH OF CHILDREN

WARNINGS AND PRECAUTIONS

Discontinue use in case of hypersensitivity to the components of Diabek-100.

WARNINGS

Keep in a cool place and away from direct sunlight.

PACKAGE LABEL

diabek-100 antiseptic gel

DIABEK-100
hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81577-2000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.000005 g in 1 g
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.00002 g in 1 g
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N)	SODIUM HYPOCHLORITE	0.000005 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)	0.002 g in 1 g
WATER (UNII: 059QF0KO0R)	0.99612 g in 1 g
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253)	0.00185 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81577-2000-2	70 g in 1 TUBE; Type 0: Not a Combination Product	03/02/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/02/2021	11/08/2022

Labeler - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)

Registrant - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)

Name	Address	ID/FEI	Business Operations
Establishment
JOAQUIN ARMANDO CARDENAS URQUIDEZ		951588416	manufacture(81577-2000)

Revised: 11/2022

Document Id: ed022232-ae4e-a080-e053-2995a90a987a

Set id: bc99de70-3289-6f2d-e053-2a95a90aead3

Version: 2

Effective Time: 20221108

JOAQUIN ARMANDO CARDENAS URQUIDEZ