H BIOTICS: Package Insert and Label Information

H BIOTICS- hypochlorous acid liquid
EMBIOME 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.

Active Ingredient

Hypochlorous ACID

PURPOSE

ANTIMICROBIAL

Inactive

WATER

Stop use

if irritationor rash occurs. These may be signs of a serious contion.

ask a doctor.

if irritationor rash occurs. These may be signs of a serious contion.

Warnings

Please do not use for any other purpose

keep put of eyes.

rinse cautiously with water of several minutes.

uses

Hand sanitizer to decrease bacteria on the skin that could cause disease

When using this product

kills over 99% of most common germs.

Keep out of reach of children.

Keep out of reach of children.

Other information

Store between 33.8~86′F
Avoid freezing and excessive heat

directions

spray on surfaces that require disinfection, sterilation and dedorization.

dry naturally.

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

LABEL

embio2
(click image for full-size original)

79045-301-02

150ML
(click image for full-size original)

H BIOTICS
hypochlorous acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79045-301
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYPOCHLOROUS ACID (HYPOCHLOROUS ACID) HYPOCHLOROUS ACID 0.01 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER 99.9 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79045-301-01 150 mL in 1 BOTTLE, SPRAY None
2 NDC:79045-301-02 20 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/22/2020
Labeler — EMBIOME Co., Ltd. (695729257)
Registrant — EMBIOME Co., Ltd. (695729257)
Establishment
Name Address ID/FEI Operations
EMBIOME Co., Ltd. 695729257 manufacture (79045-301)

Revised: 11/2020 EMBIOME Co., Ltd.

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