Label: DELPHIS ECO HAND SANITISING FOAM- benzalkonium chloride liquid
DELPHIS ECO- benzalkonium chloride liquid
DELPHIS ECO HAND SANITISER- 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 February 25, 2021

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  • Active Ingredient

    Benzalkonium Chloride 3.0% (w/v)

  • Purpose

    Antiseptic

  • Uses

    • Hand sanitiser to help reduce bacteria that potentially can cause disease.
    • For use when soap and water are not available.
  • Warning

    • For external use only.

    Do not use

    • on children less than 2 months of age
    • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. Do not ingest. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces.
    • Should be applied regularly.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other Information or Comments

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive Ingredients

    Aloe Barbadensis, Cocamide DEA, Cocamine Oxide, Didecyldimonium chloride, Fragrance, Propylene glycol, Water

  • Principal Display Panel

    Delphis Eco Hand Sanitiser (100 mL) NDC: 81560-001-01

    Hand Sanitizer 100 mL

    Delphis Eco Hand Sanitising Spray (500 mL) NDC: 81560-002-05

    Hand Sanitising Spray 500 mL

    Delphis Eco Hand Sanitising Spray (700 mL) NDC: 81560-002-07

    Hand Sanitising Spray 700 mL

    Delphis Eco Hand Sanitising Foam (5 L) NDC: 81560-003-50

    Hand Sanitising Foam 5 L

  • INGREDIENTS AND APPEARANCE
    DELPHIS ECO  HAND SANITISING FOAM
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81560-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81560-003-505000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/23/2021
    DELPHIS ECO 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81560-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81560-002-07700 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/23/2021
    2NDC:81560-002-05500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/23/2021
    DELPHIS ECO  HAND SANITISER
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81560-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81560-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/23/2021
    Labeler - DELPHIS ECO LIMITED (219500985)
    Establishment
    NameAddressID/FEIBusiness Operations
    DELPHIS ECO LIMITED219500985manufacture(81560-001, 81560-002, 81560-003)
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