K-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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k-100 antiseptic and disinfectant gel

ACTIVE INGREDIENTS SECTION

ACTIVE INGREDIENTS

Hypochlorous acid

Sodium hypochlorite

Hydrogen peroxide

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS

Carbomer 940

Water

Triethanolamine

PURPOSE SECTION

PURPOSE

ANTISEPTIC

DOSAGE AND ADMINISTRATION

Antiseptic: Clean the wound with neutral soap and apply directly (or diluted according to medical indications) on the wound, repeat the process 3 times a day or as indicated by your doctor.

INDICATIONS AND USAGE

Wash your hands with soap and water and apply K-100 Gel

WARNINGS AND PRECAUTIONS

Keep in a cool place and away from direct sunlight.

Store at room temperature away from direct sunlight

WARNINGS

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 k-100.GEL.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

k-100 antiseptic and disinfectant gel

K-100 
hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81577-5000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N) SODIUM HYPOCHLORITE0.000005 mg  in 1 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.000005 mL  in 1 mL
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.00005 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.00185 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.99609 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81577-5000-53785 mL in 1 JUG; Type 0: Not a Combination Product03/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/10/202111/24/2022
Labeler - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Registrant - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Establishment
NameAddressID/FEIBusiness Operations
JOAQUIN ARMANDO CARDENAS URQUIDEZ951588416manufacture(81577-5000)

Revised: 11/2022
Document Id: ee3d2643-7adf-50df-e053-2a95a90ad070
Set id: bd3cc2a6-e481-7a05-e053-2995a90a1f55
Version: 2
Effective Time: 20221124
 
JOAQUIN ARMANDO CARDENAS URQUIDEZ