Label: CAREN HAND SANITIZER ANTISEPTIC- benzalkonium chloride gel

  • 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 September 24, 2020

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

View All Sections
  • Active Ingredient(s)

    Benzalkonium Chloride....................Purpose: Antimicrobial and First Aid Antiseptic

  • Purpose

    Antimicrobial and First Aid Antiseptic

  • Uses

    • For hand sanitizing to decrease bacteria on the skin.  Recommended for repeated use.  
    • For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations, and sking infections.
  • Warnings

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes.  In case of eye contact, flush eyes with water.

  • STOP USE

    Discontinue use if irratation or redness develops.  If condition persists for more than 72 hours consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
    • Antiseptic: Apply to cuts, scrapes, and burns 3 times a day after cleaning.  Allow to dry.
  • Inactive ingredients

    Aloe, Carbomer, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Purified Water

  • PRINCIPAL DISPLAY PANEL

    2oz label

  • PRINCIPAL DISPLAY PANEL

    4oz label

  • PRINCIPAL DISPLAY PANEL

    32oz label

  • PRINCIPAL DISPLAY PANEL

    12oz label

  • PRINCIPAL DISPLAY PANEL

    24oz label

  • INGREDIENTS AND APPEARANCE
    CAREN HAND SANITIZER ANTISEPTIC 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77009-0420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALOE (UNII: V5VD430YW9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77009-0420-10.059 kg in 1 TUBE; Type 0: Not a Combination Product05/28/2020
    2NDC:77009-0420-20.118 kg in 1 TUBE; Type 0: Not a Combination Product05/28/2020
    3NDC:77009-0420-30.948 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/28/2020
    4NDC:77009-0420-40.354882 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/24/2020
    5NDC:77009-0420-50.709765 kg in 1 POUCH; Type 0: Not a Combination Product09/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/28/2020
    Labeler - Caren Products, LLC (932901676)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(77009-0420)
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!