HClO Disinfectant: Package Insert and Label Information

HCLO DISINFECTANT- hypochlorous acid liquid
Suzhou HVHA Medical Technology Development Co.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Main ingredient

Effective Chlorine 90-110mg/L

Properties

This product is colorless transparent liquid

Categories of microorganism to be killed

This product kills the enteric pathogenic bacteria, pyococcus, pathogenic saccharomycetes and common bacteria in nosocomial infection.

Application scope

Suitable for disinfecting hygienic hand, Air, Object surface, Fabric, Fruit and vegetable

Indication for use

1. Disinfection of hand: Spray the original solution once, take effect for 5 minutes.

2. Disinfection of air: Spray the original solution once, take effect for 20 minutes.

3. Disinfection of fabric: Spray the original solution once, take effect for 5 minutes.

4. Disinfection of surface of object: Spray the original solution once, take effect for 5 minutes.

5. Disinfection of fruit or vegetable: Spray the original solution, take effect for 5 minutes.

Notices

Use by children must be under tutelage of adult.

Keep out of reach of children and abnormal people.

Avoid high temperature or open fire

This product is acid substance and avoid using together with alkaline substance.

After the product is opened, the service life is two weeks.

This product is prohibited using together with products containing hydrochloric acid.

Function mechanism

HCLO is a kind of strong oxidant and it is decomposed into nascent oxygen which is strong oxidability to makes proteins and other substances of bacteria or virus denatured and play a bactericidal effect. HCLO infiltrates into the bacteria or virus and oxidizes with organic macromolecules such as protein, nucleic acid and enzyme, and enzymes to kill the pathogenic microorganisms. The chloride ion generated from HCLO can also significantly change the osmotic pressure of bacteria or virus, making their cells lose viability and die.

Storage

Seal and store away from light at cool temperature

Shelf life: 24 months

Inactive ingredients

Water, Sodium chloride, Sodium silicate

Purpose

Disinfect hand, air, surface of object, fabric, fruit and vegetable

Package Labeling:

HClO disinfectant 60ml 77263-001-01 label
(click image for full-size original)

HClO disinfectant 100ml 77263-001-02 label
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HClO disinfectant 500ml 77263-001-03 label
(click image for full-size original)
HClO disinfectant 1L 77263-001-04 label
(click image for full-size original)
HCLO DISINFECTANT
hypochlorous acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77263-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYPOCHLOROUS ACID (HYPOCHLOROUS ACID) HYPOCHLOROUS ACID 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
SODIUM SILICATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77263-001-01 60 mL in 1 BOTTLE None
2 NDC:77263-001-02 100 mL in 1 BOTTLE None
3 NDC:77263-001-03 500 mL in 1 BOTTLE None
4 NDC:77263-001-04 1000 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/03/2020
Labeler — Suzhou HVHA Medical Technology Development Co.,Ltd. (421344661)
Registrant — Suzhou HVHA Medical Technology Development Co.,Ltd. (421344661)
Establishment
Name Address ID/FEI Operations
Suzhou HVHA Medical Technology Development Co.,Ltd. 421344661 manufacture (77263-001)

Revised: 05/2020 Suzhou HVHA Medical Technology Development Co.,Ltd.

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