Label: FIRST MARK ULTRA FOAMING ANTIBACTERIAL- benzalkonium chloride solution

  • NDC Code(s): 51042-001-10
  • 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 June 29, 2023

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

View All Sections
  • Active Ingredient

    Benzalkonium chloride 0.5%

  • Purpose

    Antiseptic handwash

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warning

    For external use only

    Do not use

    • in eyes

    When using the product

    • if in eyes, rinse promptly and thoroughly with water
    • discontinue use if irritation and redness develop

    Stop use and ask a doctor if

    • skin irritation or redness occurs 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

    • wet hands and apply foam
    • scrub hands and forearms
    • rinsethoroughly and dry
  • Other information

    • for additional information, see Safety Data Sheet (SDS)
    • for emergency medical information in USA and Canada, call (833) 571-1403
  • INACTIVE INGREDIENT

    Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate,  phenoxyethanol, polyquaternium 7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/carate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, blue 1

  • QUESTIONS

    Questions? call 1-800-532-7732

  • Principal display panel and representative container

    REORDER% 644084

    1111218   778366   778366/7300/0521

    FIRST MARK

    ULTRA FOAMING ANTIBACTERIAL

    HAND SOAP

    Active Ingredient: Benzalkonium Chloride 0.5%

    NDC 51042-001-10

    Made in the USA

    DISTRIBUTED BY:

    PERFORMANCE FOOD GROUP

    12500 WEST CREEK PARKWAY

    RICHMOND VIRGINIA 23238

    representative label

  • INGREDIENTS AND APPEARANCE
    FIRST MARK ULTRA FOAMING ANTIBACTERIAL 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51042-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51042-001-101250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/12/2015
    Labeler - Performance Food Group (127038714)
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!