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.

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diabek-100 antiseptic solution

ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Hypochlorous acid

Sodium hypochlorite

Hydrogen peroxide

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS

WATER

PURPOSE SECTION

PURPOSE

ANTISEPTIC

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

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.

STOP USE SECTION

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

WARNINGS AND PRECAUTIONS SECTION

Keep in a cool place and away from direct sunlight.

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

diabek-100 antiseptic solution

DIABEK-100 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81577-3000
Route of AdministrationTOPICAL
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 ACID0.00002 mg  in 1 mL
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N) SODIUM HYPOCHLORITE0.000005 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.99997 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81577-3000-3240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/11/202111/24/2022
Labeler - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Registrant - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Establishment
NameAddressID/FEIBusiness Operations
JOAQUIN ARMANDO CARDENAS URQUIDEZ951588416manufacture(81577-3000)

Revised: 11/2022
Document Id: ee3d21a7-155b-3452-e053-2a95a90a3d1c
Set id: bcc11b6e-43ca-6f4f-e053-2a95a90ab93d
Version: 2
Effective Time: 20221124
 
JOAQUIN ARMANDO CARDENAS URQUIDEZ