Label: HAND SANITIZER- benzalkonium chloride spray

  • 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 September 22, 2021

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE 0.1%

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • For hand sanitizing to decrease bacteria
    • Recommended for repeated use
  • WARNINGS

    For extrenal use only

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

    Stop use and ask a doctor if imitation or redness develops, or if condition persists 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

    Spray a small amount into palm of hand

    • Rub thoroughly over all surfaces of both hands
    • Rub hands together briskly until dry.
  • INACTIVE INGREDIENTS

    water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth–17 cocoate, citric acid, lavender 4042, Eucalyplus 80/85.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Skywash_Hand Sanitizer_8oz

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78987-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78987-101-11238 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/23/2020
    Labeler - Skywash International (066107480)
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