Label: BIOPURE SHIELD- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 13, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BIOPURE SHIELD 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78674-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
    OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78674-100-0150.68 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/22/2020
    Labeler - Biopure Services Llc (117539774)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!