Label: BENZA CLEAN 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 26, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13% 

  • Purpose

    Antimicrobial and First Aid Antiseptic

  • Uses

    For hand sanitizing to decrease bacteria on the skin. As a wound antiseptic to help prevent bacterial contamination in cuts, burns, scrapes, lacerations and skin infections.

  • Warnings

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes. Incase of eye contact, flush eyes with water.
    Discontinue useif irritation 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

    • Pump onto hands as needed. Rub briskly until dry.
    • Apply to wounds 3 times per day after cleaning. Allow to dry. May be bandaged once dry.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water, Sodium Bicarbonate, Colalipid C, Hydroxyethyl Cellulose, Green Tea Leaf Extract.

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    BENZA CLEAN HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79832-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79832-001-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    2NDC:79832-001-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Labeler - BIOSYN INC (079797906)
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