Label: SAFE AND SOFT ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

  • 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 15, 2022

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

View All Sections
  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antiseptic

  • Use

    Hand sanitizer to reduce bacteria on the skin.

  • Warnings

    For external use only-hands

    When using this product

    • Do not use in or near eyes 
    • In case of contact with eyes, flush thoroughly with water 
    • Avoid contact with broken skin

    Stop use and ask a doctor if

    skin irritation develops

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wipe hands thoroughly with product and allow to dry
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Inactive ingredients

    water, polysorbate 20, glycerin, phenoxyethanol, aloe (aloe barbadensis) leaf juice, fragrance, methylparaben, tocopheryl acetate, tetrasodium EDTA, disodium cocoamphodiacetate, butylparaben, citric acid, ethylparaben, propylparaben

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    SAFE AND SOFT ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23957-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23957-001-7272 in 1 BOX08/01/2020
    10.13 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    Labeler - Albaad USA, Inc (143406457)
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!