ANTIBACTERIAL HAND FREE- benzalkonium chloride gel 
ZHONGSHAN DIOS TRADING COMMERCIAL CO., LTD.

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 Fact

Active Ingredient(s)

BENZALKONIUM CHLORIDE: 0.1%

Purpose

Antiseptic

Use

Use: Used for antibacterial cleaning of hand skin

Warnings

Warning: For external use only. Discontinue use if skin irritation occurs. Avoid contact with eyes. Flammable. Keep away from fire source

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

Directions: Apply appropriate amount to plams, rub your hands quickly untill they are dry. Also be sure to clean your finger tips, finger joints and other parts. Don't need to wash

Inactive ingredients

Inactive Ingredients: Alcohol, Water, Carbomer, Sodium Hydroxide

Storage: Store in cool dry place away from light at room temperature

Package Label - Principal Display Panel

image description

ANTIBACTERIAL HAND FREE 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74532-002
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
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74532-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/04/2020
Labeler - ZHONGSHAN DIOS TRADING COMMERCIAL CO., LTD. (542141447)
Establishment
NameAddressID/FEIBusiness Operations
ZHONGSHAN DIOS TRADING COMMERCIAL CO., LTD.542141447manufacture(74532-002)

Revised: 4/2020
Document Id: a2a412ea-c27e-9ad3-e053-2995a90aa0e8
Set id: f69f4fbc-ce57-4514-b7e6-1f983c134065
Version: 1
Effective Time: 20200406
 
ZHONGSHAN DIOS TRADING COMMERCIAL CO., LTD.