OTC Medication Information: K-100

K-100- hydrogen peroxide, hypochlorous acid and sodium hypochlorite 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.

ACTIVE INGREDIENTS

Hypochlorous acid

Sodium hypochlorite

hydrogen peroxide

INACTIVE INGREDIENTS

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

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

K-100 ANTISEPTIC AND DISINFECTANT (3785 ml ) 1 GALLON
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K-100 ANTISEPTIC AND DISINFECTANT 240 ml
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K-100 ANTISEPTIC AND DISINFECTANT
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K-100
hydrogen peroxide solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81577-4000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE 0.000005 mL in 1 mL
HYPOCHLOROUS ACID (HYPOCHLOROUS ACID) HYPOCHLOROUS ACID 0.00006 mg in 1 mL
SODIUM HYPOCHLORITE (HYPOCHLORITE ION) SODIUM HYPOCHLORITE 0.000005 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER 0.99993 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81577-4000-4 1000 mL in 1 BOTTLE None
2 NDC:81577-4000-5 240 mL in 1 BOTTLE, SPRAY None
3 NDC:81577-4000-6 3785 mL in 1 JUG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/05/2021
Labeler — JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Registrant — JOAQUIN ARMANDO CARDENAS URQUIDEZ (951588416)
Establishment
Name Address ID/FEI Operations
JOAQUIN ARMANDO CARDENAS URQUIDEZ 951588416 manufacture (81577-4000)

Revised: 09/2021 JOAQUIN ARMANDO CARDENAS URQUIDEZ

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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