BIOPURE SHIELD- benzalkonium chloride liquid

bioPURE Shield by

Drug Labeling and Warnings

bioPURE Shield by is a Otc medication manufactured, distributed, or labeled by Biopure Services Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Benzalkonium Chloride 0.13%.

PURPOSE

Purpose: Antiseptic/Antimicrobial.

INDICATIONS & USAGE

Uses: For hand washing to help reduce bacteria on the skin that could cause disease.

DOSAGE & ADMINISTRATION

Directions: Foam onto palm, massage into hands and under fingernails, and air dry. Young children use with supervision.

STORAGE AND HANDLING

Store: At room temperature not below 33°F.

INACTIVE INGREDIENT

Other Ingredients: Purified Water, Propylene Glycol, Methyl Anthranilate, Trihydroxysilylpropyldimethylocatedecyl Ammonium Chloride.

WARNINGS

CAUTION: FOR EXTERNAL USE ONLY
Avoid contact with eyes. In case of contact, flush with water.
Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, contact a physician.

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, get medical help or contact the Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

​ANTIBACTERIAL FOAM

PROTECTS SIGNIFICANTLY LONGER THAN ALCOHOL

HOURS OF PROTECTION

WASH - DRY - APPLY

FDA REGISTERED

NO ALCOHOL

WATER-BASED

SAFE FOR KIDS

EFFECTIVE AGAINST 99.9% - 99.99% OF COMMON BACTERIA AND MANY DISEASE-CAUSING GERMS

This bottle is recyclable. Do your part.

bioPURE SHIELD™ (BPS-MAX HS) antimicrobial foam kills germs on contact, plus its unique antiseptic formula continues to kill and protect significantly longer than alcohol without causing skin irritation.

30-day supply when used as directed.
info@biopureservice.com | www.biopureservice.com

Distributed by bioPURE Services LLC, 6221 Riverside Drive,
#1N, Dublin, OH 43017

MADE IN THE USA

Packaging

INGREDIENTS AND APPEARANCE

BIOPURE SHIELD 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78674-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL ANTHRANILATE (UNII: 981I0C1E5W)
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78674-100-01	50.68 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/22/2020

Labeler - Biopure Services Llc (117539774)