Label: FIRST MARK FOAMING HAND CLEANER- benzethonium chloride liquid

  • NDC Code(s): 51042-692-12, 51042-692-17, 51042-692-41
  • Packager: Performance Food Group
  • 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 July 25, 2023

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  • Purpose

    Antibacterial Agent

  • Active Ingredient

    Benzethonium Chloride 0.2% w/w

  • Uses

    • To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.
  • Warnings

    • For external use only.

    • Avoid contact with eyes. If contact occurs, flush with water.

    • Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.   

    • Keep out of reach of children. If swallowed, contact a physician or poison control center.
  • Directions

    • To decrease bacteria on skin, apply small amount to palm.  Brisky rub, covering hands with product until dry.
  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Ethanol, Fragrance, Aloe Barbadensis Leaf, Tocopheryl Acetate, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Propylene Glycol, Phenoxyethanol, Tetrasodium EDTA

  • Principal display panel and representative label

    REORDER# 

    253357

    FIRST

    MARK

    THE MARK OF QUALITY IN

    NON-FOOD ESSENTIALS

    FOAMING

    INSTANT

    HAND SANITIZER

    33.8 Fl. Oz. (1000 mL)

    DISTRIBUTED BY:

    PERFORMANCE FOOD GROUP

    12500 WEST CREEK PARKWAY

    RICHMOND, VA 23238

    SDS-OH-158

    Representative label

  • INGREDIENTS AND APPEARANCE
    FIRST MARK  FOAMING HAND CLEANER
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51042-692
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51042-692-411000 mL in 1 BAG; Type 0: Not a Combination Product06/23/201007/25/2023
    2NDC:51042-692-1750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/201007/25/2023
    3NDC:51042-692-121000 mL in 1 BAG; Type 0: Not a Combination Product06/23/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/23/2010
    Labeler - Performance Food Group (127038714)
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