K-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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K-100 antiseptic and disinfectant

ACTIVE INGREDIENTS

Hypochlorous acid

Sodium hypochlorite

hydrogen peroxide

INACTIVE INGREDIENTS

Water

INDICATIONS AND USAGE SECTION

Clean the wound with soap and water and pat dry with sterile gauze pad.

Disinfect the wound with k-100 by applying it directly to the wound and allowing the product to dry out completely.

allow it to act for 5 minutes then wipe dry any excess product with a cloth or rag no need to rinse.

PURPOSE

PURPOSE ANTISEPTIC

DOSAGE AND ADMINISTRATION

Clean the wound with soap and water and pat dry with sterile gauze pad.

Disinfect the wound with k-100 by applying it directly to the wound and allowing the product to dry out completely.

allow it to act for 5 minutes then wipe dry any excess product with a cloth or rag no need to rinse.

ASK A DOCTOR

In case of ingestion drink water and consult your doctor

WARNINGS AND PRECAUTIONS

For external use only.

Avoid direct contact with eye.

WARNINGS

store in a place below 86° F (30° C), and avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

K-100 ANTISEPTIC AND DISINFECTANT (3785 ml ) 1 GALLON

K-100
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81577-4000
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 mL in 1 mL
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.00006 mg in 1 mL
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N)	SODIUM HYPOCHLORITE	0.000005 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	0.99993 mL in 1 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81577-4000-4	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2021
2	NDC:81577-4000-5	240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/05/2021
3	NDC:81577-4000-6	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/05/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/05/2021	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(81577-4000)

Revised: 11/2022

Document Id: ed01fbf7-7a59-4b94-e053-2995a90a0772

Set id: bcd87fed-655d-ca8d-e053-2995a90a6fea

Version: 3

Effective Time: 20221108

JOAQUIN ARMANDO CARDENAS URQUIDEZ