ANTIBACTERIAL WIPES- benzalkonium chloride swab 
Orazen Inc

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(s)

Packaging ArtworkBenzalkonium Chloride 0.13 % v/v. Purpose: Antiseptic

Purpose

Antibacterial, Wipe

Use

Decrease bacteria on skin. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

Inactive ingredients

Water, Propylene Glycol, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Fragrance

Package Label - Principal Display Panel

30ct NDC: 69821-001-25 Package Label Principal

ANTIBACTERIAL WIPES 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71927-010-010.1 mL in 1 POUCH; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Orazen Inc (080916640)
Establishment
NameAddressID/FEIBusiness Operations
Orazen Inc080916640relabel(71927-010)
Establishment
NameAddressID/FEIBusiness Operations
Zhegiang Qimei Commodity Co/ Ltd544331136manufacture(71927-010)

Revised: 5/2020
Document Id: a609ec7f-bfea-2d81-e053-2a95a90a0ca6
Set id: a609ec7f-bfe9-2d81-e053-2a95a90a0ca6
Version: 1
Effective Time: 20200518
 
Orazen Inc