ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride gel 
Aogrand International Trade Corporation

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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Antibacterial Hand Sanitizer

Active Ingredient(s)

Benzalkonium Chloride 0.1%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Warnings

For external use only.

Do not apply around eyes. Do not use in ears & mouth.

When using this product

avoid contact with eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor

if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Directions

Inactive ingredients

Cocamidopropylamine oxide, C12-20 Alkyl glycoside, glycerin, hydroxyethyl cellulose, Casone (methylisothiazolinone and methylchloroisothiazolinone), citric acid, deionized water

Other information

Package Label - Principal Display Panel

1180ml NDC: 74621-007-01

PDP

1500ml NDC: 74621-007-02

PDP

ANTIBACTERIAL HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74621-007
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
WATER (UNII: 059QF0KO0R)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74621-007-011180 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/2020
2NDC:74621-007-021500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/23/2020
Labeler - Aogrand International Trade Corporation (421353092)
Establishment
NameAddressID/FEIBusiness Operations
Aogrand International Trade Corporation421353092manufacture(74621-007)

Revised: 2/2023
Document Id: f47a1f19-23ea-5f95-e053-2a95a90a093d
Set id: a6565248-ab5d-61f0-e053-2a95a90a8041
Version: 3
Effective Time: 20230211
 
Aogrand International Trade Corporation