Label: INSTA SAN- benzalkonium chloride liquid

  • 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 24, 2020

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  • Active Ingredient

    Benzalkonium chlorinde, 0.1% w/v

  • Purpose

    Antimicrobial

  • Use

    • For hand sanitizing to decrease bacteria on skin.
    • Recommended for repeated use.
  • Warning

    For external use only.

  • When using this product

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

  • Stop use and ask a doctor if

    Stop use and ask a doctor if irritation or redness develops, or if conditions perist for more that 72 hours.

  • 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.

  • Directions

    ▪ Pump a small amount of foam into palm of hand

    ▪ Rub thoroughly over all surfaces of both hands

    ▪ Rub hands together briskly until dry

  • INACTIVE INGREDIENT

    Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

  • Questions

    Question or comments? 320-693-2477

  • First Aid

    Eye contact: Flush immediately with plenty of water for 15 minutes. Lift upper and lower eyelids for
    complete rinsing. If irritation persists after rinsing, get medical attention.
    Skin Contact: If irritation occurs, discontinue use. If irritation persists, call a physician.
    Ingestion: Drink 1 or 2 glasses of water. Call a physician.

  • Principal Display Panel

    Jug Label

  • INGREDIENTS AND APPEARANCE
    INSTA SAN 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63131-1134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63131-1134-17570 in 1 CASE04/17/2020
    13785 mL in 1 JUG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2020
    Labeler - Anderson Chemical Company (006179220)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anderson Chemical Company006179220manufacture(63131-1134)
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