Label: SAFETY GOLD ANTIBACTERIAL HAND- benzalkonium chloride soap

  • NDC Code(s): 22431-586-01, 22431-586-02, 22431-586-03, 22431-586-04
  • Packager: Blue Cross Laboratories
  • 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 January 5, 2023

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

View All Sections
  • 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 right away.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if irritation and redness develops

  • WARNINGS

    Warnings

    For external use only

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands as needed
    • Lather vigorously for at least 15 seconds
    • rinse and dry thoroughly
  • INACTIVE INGREDIENT

    Inactive ingredients Water(aqua), Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Fragrance, Citric Acid, D&C Orange #4, D&C Yellow #10

  • PRINCIPAL DISPLAY PANEL

    Safety Gold

    Antibacterial Hand Soap

    Kills Germs

    Cleans & Softens Hands

    16 FL OZ (473 mL)

    BLU SAFETY Antibacterial HS BACK

    BLU SAFETY Gold Antibacterial HS

  • INGREDIENTS AND APPEARANCE
    SAFETY GOLD ANTIBACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-586
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-586-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    2NDC:22431-586-02473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    3NDC:22431-586-031180 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
    4NDC:22431-586-04444 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/26/2020
    Labeler - Blue Cross Laboratories (008298879)
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!