BIOXYGEN ANTISEPTIC HAND SANITIZER- isopropyl alcohol liquid

BiOxygen Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

BiOxygen Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by U S Fluids Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Isoprpoyl alcohol 70% v/v

Purpose

Antiseptic

Uses

▪ hand sanitizer to decrease bacteria on the skin

▪ recommended for repeated use

▪ for use when soap and water are not available

Warnings

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

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

Directions

▪ 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

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

INACTIVE INGREDIENT

Inactive ingredients  glycerin, hydrogen peroxide, hydroxyethylcellulose, water

QUESTIONS

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

INGREDIENTS AND APPEARANCE

BIOXYGEN ANTISEPTIC HAND SANITIZER 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75189-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 L  in 1 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75189-100-02	0.06 L in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
2	NDC: 75189-100-04	0.12 L in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
3	NDC: 75189-100-08	0.24 L in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
4	NDC: 75189-100-10	0.3 L in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
5	NDC: 75189-100-01	3.79 L in 1 JUG; Type 0: Not a Combination Product	05/01/2020
6	NDC: 75189-100-05	18.93 L in 1 JUG; Type 0: Not a Combination Product	05/01/2020
7	NDC: 75189-100-30	113.56 L in 1 DRUM; Type 0: Not a Combination Product	05/01/2020
8	NDC: 75189-100-55	208.20 L in 1 DRUM; Type 0: Not a Combination Product	05/01/2020
9	NDC: 75189-100-75	1041 L in 1 CONTAINER; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - U S Fluids Inc (139405646)

Establishment
Name	Address	ID/FEI	Business Operations
U S Fluids Inc		139405646	manufacture(75189-100)