Label: DISINFECT AND SHIELD HAND SANITIZER FOAM- 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 August 10, 2020

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

View All Sections
  • DRUG FACTS

  • ACTIVE INGREDIENT:

    Benzalkonium Chloride 0.13%

  • PURPOSE

    PURPOSE: Antiseptic/Hand & Skin Sanitizer

  • INDICATIONS & USAGE

    USES: Hand Sanitizer to help decrease bacteria on the skin - Recommended for repeated use.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Apply liberally to the palms of the hands. Rub into skin until dry. Recommended for repeat use.

  • STORAGE AND HANDLING

    OTHER INFORMATION: Do not Freeze. Store below 150° F (66°C)

  • INACTIVE INGREDIENTS:

    Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.

  • WARNINGS:

    • For external use only.

    • When using this product do not use in or near eyes.

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

    • Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center immediately hours.

  • QUESTIONS

    IN CASE OF EMERGENCY CONTACT 1-346-293-7265

  • SPL UNCLASSIFIED SECTION

    8-HOUR SHIELD

    FOAMING FORMULA

    WITH SOOTHING ALOE VERA

    ALCOHOL-FREE

    GUARDS AGAINST INFECTION

    EXTENDED PROTECTION

    SOOTHING FORMULA

    Formulated with

    Zetrisil

    Dist. By: D&S, 3 Riverway Suite 1430,

    Houston, Texas 77056

    MADE IN USA

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    DISINFECT AND SHIELD HAND SANITIZER FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71884-022
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    LAURETH-4 (UNII: 6HQ855798J)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71884-022-0259.14 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2020
    2NDC:71884-022-123785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/10/2020
    Labeler - Enviro Specialty Chemicals Inc (202621850)
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!