FDA.reportPublic FDA data

BiOxygen Antiseptic Hand Sanitizer

Manufacturer
U S Fluids Inc
Effective date
2022-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:18:37

Label at a glance#

ProductBiOxygen Antiseptic Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Indications and uses

▪ hand sanitizer to decrease bacteria on the skin ▪ recommended for repeated use ▪ for use when soap and water are not available

Dosage and administration

▪ wet hands thoroughly with product and allow to dry without wiping. ▪ supervise children under 6 years of age when using this product to avoid swallowing.  

Storage and handling

▪ store between 15-30°C (59-83°F)  ▪ a void freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isoprpoyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

▪ hand sanitizer to decrease bacteria on the skin

▪ recommended for repeated use

▪ for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame.

For external use only.

Do not use  ▪ on children less than 2 months of age

                    ▪ on open skin wounds

When using this product ▪ do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if ▪ irritation and redness develop.  

                                                ▪ condition persists more than 72 hours

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

▪ wet hands thoroughly with product and allow to dry without wiping.

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

Other information

STORAGE AND HANDLING SECTION

▪ store between 15-30°C (59-83°F) ▪ a void freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients  glycerin, hydrogen peroxide, hydroxyethylcellulose, water

OTC - QUESTIONS SECTION

Questions?  +1-212-574-0784

You may also report serious side effects to this phone number.

Mon-Fri 9.00 AM- 5.00 PM

SPL UNCLASSIFIED SECTION

Manufactured for Ener.co, 747 Third Avenue, New York, NY, 10017

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75189-10075189-100-02, 75189-100-04, 75189-100-08, 75189-100-10, 75189-100-01, 75189-100-05, 75189-100-30, 75189-100-55, 75189-100-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
229a00fc-5741-4013-bddc-d5c1e405cdd50a9bdfbf-4c9a-4815-9980-981f39b7ffbc2022-01-06WarningsExact identifier
spl id: 229a00fc-5741-4013-bddc-d5c1e405cdd5
spl set id: 0a9bdfbf-4c9a-4815-9980-981f39b7ffbc

Reported adverse events (FAERS/openFDA)#

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