DELPHIS ECO HAND SANITISING FOAM- benzalkonium chloride liquid 
DELPHIS ECO- benzalkonium chloride liquid 
DELPHIS ECO HAND SANITISER- benzalkonium chloride liquid 
DELPHIS ECO LIMITED

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.

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Delphis Eco Hand Sanitiser

Active Ingredient

Benzalkonium Chloride 3.0% (w/v)

Purpose

Antiseptic

Uses

Warning

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

Other Information or Comments

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

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)

Revised: 2/2021
Document Id: ba9a6122-b05a-2358-e053-2995a90a43d4
Set id: ba9a6122-b059-2358-e053-2995a90a43d4
Version: 1
Effective Time: 20210225
 
DELPHIS ECO LIMITED