Label: SMART HAND SANITIZER- 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 September 22, 2020

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

  • SPL UNCLASSIFIED SECTION

    no alcohol

    dye and fragrance free

    tough on germs and bacteria

    Smart Plastic

    San Diego, CA 92121

    WARNING

    KEEP OUT OF REACH OF CHILDREN.

    MAY BE HARMFUL IF SWALLOWED.

    MAY CAUSE EYE IRRITATION.

    SEE BACK PANEL FOR ADDITIONAL PRECAUTIONS AND FIRST AID.

    institutional & commercial hand Sanitizer

    MFG By: Chemcor Chemical Corporation

    13770 Benson Avenue, Chino, CA 91710

    1877- CHEMCOR

    www.ChemcorChemical.com

    Before discarding container, rinse with water.

    For institutional and commercial use.

  • Active Ingredient(s)

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Use

    • For hand sanitizing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only

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

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

  • Directions

    • Pump a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together briskly until dry
  • Inactive Ingredients

    Water, d-glucopyranose, oligomeric, decyl octyl glycosides, glycerol, methylisothiazolinone and citric acid

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Packaging

    3785mL NDC: 79192-555-01 3785mL

  • INGREDIENTS AND APPEARANCE
    SMART HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79192-555(NDC:68041-519)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYL OLIGOGLUCOSIDE (UNII: VXR09E583M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    2,3 DI-O-METHYL-D-GLUCOSE (UNII: 3F1Y194PDX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79192-555-013785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/22/2020
    Labeler - Smart Plastic (117552677)
    Establishment
    NameAddressID/FEIBusiness Operations
    Smart Plastic117552677relabel(79192-555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trimeda Tech Inc.117658787repack(79192-555)