H BIOTICS

Manufacturer: EMBIOME Co., Ltd.
Effective date: 2021-11-11
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:44:54

Label at a glance#

ProductH BIOTICS

Active ingredientHYPOCHLOROUS ACID

Label structure12 sections

Indications and uses

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

Dosage and administration

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 contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hypochlorous ACID

PURPOSE

OTC - PURPOSE SECTION

ANTIMICROBIAL

Inactive

INACTIVE INGREDIENT SECTION

WATER

Stop use

OTC - STOP USE SECTION

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

ask a doctor.

OTC - ASK DOCTOR SECTION

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

Warnings

WARNINGS SECTION

Please do not use for any other purpose

keep put of eyes.

rinse cautiously with water of several minutes.

uses

DOSAGE & ADMINISTRATION SECTION

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

When using this product

OTC - WHEN USING SECTION

kills over 99% of most common germs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Other information

OTHER SAFETY INFORMATION

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

directions

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

embio279045-301-01

79045-301-02 150ML

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1604557	hypochlorous acid 0.01 % Topical Solution	PSN	4
1604557	hypochlorous acid 0.1 MG/ML Topical Solution	SCD	4
1604557	hypochlorous acid 0.01 % Topical Solution	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79045-301-01	2023-01-30	C162847	48780-1	f386c649-d1dd-0266-e053-dadaa90a7c1a	sanitizer
79045-301-02	2023-01-30	C162847	48780-1	f386c649-d1dd-0266-e053-dadaa90a7c1a	sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79045-301-01	H BIOTICS	150 mL in 1 BOTTLE, SPRAY	LIQUID	150		4
79045-301-02	H BIOTICS	20 mL in 1 BOTTLE	LIQUID	20		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79045-301	H BIOTICS (HYPOCHLOROUS ACID) LIQUID [EMBIOME CO., LTD.]	4	Legacy NDC, 2 package rows	20211113_a8776c09-a2d9-71fd-e053-2995a90aae93.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

H BIOTICS
Hypochlorous acid
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79045-301	79045-301-01, 79045-301-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYPOCHLOROUS ACID	712K4CDC10	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d080ac12-08df-cba1-e053-2a95a90a20a9			a8776c09-a2d9-71fd-e053-2995a90aae93	2021-11-11	Warnings	Exact identifier spl id: d080ac12-08df-cba1-e053-2a95a90a20a9 spl set id: a8776c09-a2d9-71fd-e053-2995a90aae93

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.