k-100 antiseptic and disinfectant gel

K-100 by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 
hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81577-5000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N)	SODIUM HYPOCHLORITE	0.000005 mg  in 1 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.000005 mL  in 1 mL
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.00005 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81577-5000-5	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/10/2021	11/24/2022

Labeler - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)

Registrant - JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)

Establishment
Name	Address	ID/FEI	Business Operations
JOAQUIN ARMANDO CARDENAS URQUIDEZ		951588416	manufacture(81577-5000)

Revised: 11/2022

Document Id: ee3d2643-7adf-50df-e053-2a95a90ad070

34390-5

Set id: bd3cc2a6-e481-7a05-e053-2995a90a1f55

Version: 2

Effective Time: 20221124