Label: AERISGUARD ACTISAN HAND SANITIZER- benzalkonium chloride solution

  • 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 12, 2022

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

  • Active Ingredients

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    For hand sanitizing to decrease bacteria on the skin

  • WARNINGS

    For External use only

    When using this product avoid contact with eyes.

    If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    • if irritation or redness develops
    • 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

    • Apply enough product to cover hands
    • Rub together until dry without wiping
  • Other Information

    Store at room temperature

  • Inactive Ingredients

    water, cocamidopropyl betaine, PEG-7 glyceryl cocoate, propylene glycol, tetrasodium edta, phenoxyethanol, sodium benzoate, lactic acid

  • PRINCIPAL DISPLAY PANEL

    For

    sensitive

    skin

    0% Alcohol

    aeris

    guard

    ACTISAN

    Hand Sanitizer

    Complies with EN-13727-Bactericidal test

    For sensitive skin Leaves soft skin feel

    Contains moisturizer and emollient Mild and skin compatible

    Non-tacky

    Active moisturizer

    Fragrance free and pH balanced

    ALCOHOL

    FREE

    NET CONTENTS

    3.5 fl. oz. (103mL)

    container labelATL

  • INGREDIENTS AND APPEARANCE
    AERISGUARD ACTISAN HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81124-001
    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
    LACTIC ACID (UNII: 33X04XA5AT)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81124-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2020
    2NDC:81124-001-02103.5 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2020
    3NDC:81124-001-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2020
    4NDC:81124-001-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2020
    5NDC:81124-001-05473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2020
    6NDC:81124-001-06946 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2020
    7NDC:81124-001-073800 mL in 1 PAIL; Type 0: Not a Combination Product11/24/2020
    8NDC:81124-001-0819000 mL in 1 PAIL; Type 0: Not a Combination Product11/24/2020
    9NDC:81124-001-09209000 mL in 1 DRUM; Type 0: Not a Combination Product11/24/2020
    10NDC:81124-001-101045000 mL in 1 TANK; Type 0: Not a Combination Product11/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/24/2020
    Labeler - Aeris Environmental LLC (117533699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seatex, LLC026647404manufacture(81124-001)