FDA.reportPublic FDA data

bioDefender (Hypochlorous Acid Water)

Manufacturer
WeThinking Biotech Co., Ltd.
Effective date
2022-01-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:13:36

Label at a glance#

ProductbioDefender (Hypochlorous Acid Water)
Active ingredientHYPOCHLOROUS ACID
Label structure12 sections

Dosage and administration

Use as liquid Sterilization by immersing completely for about 3 to 5 minutes. For instruments that are difficult to deposit, spray and sterilize for about 3 minutes before wiping off.

Storage and handling

Use this product only below 65˚C Do not deposit for more than 30 minutes to prevent corrosion and damage to equipment made of ferrous metal.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Hypochlorous Acid 0.1 mg/ml

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

To prevent and treat an infection of the skin.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

If sensitive to chlorine compounds

Do not mix with other chemicals

Use sterilization tank only with plastic or SUS-316 or higher material for complete sterilization

Please do not drink

Use within 18 months from the date of manufacture for complete sterilization.

OTC - WHEN USING SECTION

Stop use and ask a doctor if redness, irritation or swelling or pain persists or increases.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if redness, irritation or swelling or pain persists or increases

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Use as liquid Sterilization by immersing completely for about 3 to 5 minutes. For instruments that are difficult to deposit, spray and sterilize for about 3 minutes before wiping off.

Other information

STORAGE AND HANDLING SECTION

Use this product only below 65˚C

Do not deposit for more than 30 minutes to prevent corrosion and damage to equipment made of ferrous metal.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front and Back LabelsFront and Back Labels100 mL NDC: 80054-001-01

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80054-00180054-001-01

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
NameUNIIKind
HYPOCHLOROUS ACID712K4CDC10ACTIB
WATER059QF0KO0RIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d79cf83a-ebee-4bb7-e053-2a95a90a85a7ad331ffe-40b9-7dff-e053-2995a90a70582022-02-09WarningsExact identifier
spl set id: ad331ffe-40b9-7dff-e053-2995a90a7058

Reported adverse events (FAERS/openFDA)#

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