PERSONAL CARE FOAMING HAND SANITIZER- benzalkonium chloride liquid 
Delta Brands & Products LLC

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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Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Uses

for washing hands to decrease bacteria on the skin

Warnings

For external use only

When using this product

■ avoid contact with the eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if

■ irritation or rash develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ pump into hands ■ lather vigorously for at least 15 seconds ■ rinse and dry thoroughly.

Inactive ingredients

water (aqua), laureth-9, disodium cocoamphodiacetate, polyquaternium-10, citric acid, fragrance, glycerin, methylchloroisothiazolinone, methylisothiazolinone, FD&C blue no. 1, FD&C yellow no. 5

Package Label

Paackage Label

PERSONAL CARE  FOAMING HAND SANITIZER
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-150
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLIDOCANOL (UNII: 0AWH8BFG9A)  
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72133-150-75221.8 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/02/2018
Labeler - Delta Brands & Products LLC (080999173)

Revised: 4/2018
Document Id: 69adf628-030a-8437-e053-2991aa0abc9a
Set id: 69adf628-0308-8437-e053-2991aa0abc9a
Version: 1
Effective Time: 20180412
 
Delta Brands & Products LLC