Label: SAFETY CLEAR ANTIBACTERIAL HAND- 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 26, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Benzalkonium Chloride 0.13% Antibacterial

  • PURPOSE

    Uses For hand washing to decrease bacteria on the skin

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

    Warnings :

    For external use only

    when using this product

    • Avoid contact with eyes. If case of eye contact, flush with water
  • INDICATIONS & USAGE

    Stop use and ask a doctor if irritation and redness develops.

  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands as needed
    Lather vigorously for at least 15 seconds
    Wash skin, rinse and dry thoroughly

  • INACTIVE INGREDIENT

    Inactive ingredients Water(aqua), Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Fragrance, Citric Acid, Aliz Violet Dye

  • PRINCIPAL DISPLAY PANEL

    Safety Antibacterial

    Clear

    Hand Soap

    Cleans & Softens Hands

    8 FL OZ (236 mL)

    03343 Safety Clear Antibac Hand Soap

    03344 Safety Clear Antibac HS BACK

  • INGREDIENTS AND APPEARANCE
    SAFETY CLEAR ANTIBACTERIAL HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-587
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-587-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2020
    2NDC:22431-587-021180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2020
    3NDC:22431-587-03444 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2020
    Labeler - Blue Cross Laboratories, Inc (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blue Cross Laboratories008298879manufacture(22431-587)
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