Label: SOAPBOX ANTIBACTERIAL HAND WIPES UNSCENTED- 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 December 22, 2020

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

  • Use:

    Hand sanitizer to help reduce bacteria on the skin. For use when soap and water not available.

  • Warnings

    For external use only

    When using this product

    • Avoid getting into the eyes. 
    • In case of eye contact immediately flflush eyes thoroughly with water.

    Stop use and ask a doctor if

    • Irrtation or redness develops
    • Conditions persist for more than 72 hours
    • Redness is present

    Keep out of reach of children.

    In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

  • Directions

    • Throughly wipe hands with cloth 
    • Rub hands together until dry 
    • No rinsing required
  • Other Information

    • Dispose of properly, do not flush
  • Inactive Ingredients

    Water, Polysorbate 20, Glycerin, Potassium Sorbate, Aloe (Aloe Barbadensis) Leaf Extract, Dehydroacetic Acid, Phenoxyethanol, Citric Acid.

  • Package Labeling:20 Wipes

    PouchLabel

  • Package Labeling:50 Wipes

    Pouch2Label2

  • Package Labeling:400 Wipes

    Pouch3Label3

  • INGREDIENTS AND APPEARANCE
    SOAPBOX ANTIBACTERIAL HAND WIPES UNSCENTED 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75115-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75115-001-0120 in 1 POUCH12/15/2020
    14.54 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:75115-001-0250 in 1 POUCH12/15/2020
    24.54 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:75115-001-03400 in 1 CANISTER12/15/2020
    34.54 mL 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 finalpart333E12/15/2020
    Labeler - Soapbox Soaps, LLC (034861706)
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