ANTISEPTIC TOWELETTES- benzalkonium chloride cloth 
Custom Kits Company 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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Antiseptic Towelette

Drug Facts

Active Ingredients

Benzalkonium chloride .4%

Purpose Section

Antiseptic

Uses

Antiseptic to help prevent the risk of infection

Warning

For External Use Only

Do Not

use in the eyes

use as a first aid antiseptic longer than 1 week

apply over large areas of the body

Stop Use

if the condition persists or gets worse

Ask a doctor in case of

deep or puncture wounds, animal bites, or serious burns

Keep out of reach of children section

If swallowed, get medical help or contact a poison control center right away.

Directions

Clean the affected area

apply a small amount of the product on the area

may be covered with a sterile bandage

if bandaged let dry first

Other information

store at room temperature 20-25C (68-77 F)

Inactive Ingredients

Sodium bicarbonate, water

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ANTISEPTIC TOWELETTES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68183-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68183-120-0110 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product10/22/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/22/2015
Labeler - Custom Kits Company Inc (928643712)
Establishment
NameAddressID/FEIBusiness Operations
Dynarex Corporation008124539manufacture(68183-120)
Establishment
NameAddressID/FEIBusiness Operations
Custom Kits Company Inc928643712repack(68183-120) , relabel(68183-120)

Revised: 12/2017
Document Id: 615453a8-ae7d-1b4a-e053-2a91aa0afcd4
Set id: 22b24f35-9ffe-4950-e054-00144ff88e88
Version: 2
Effective Time: 20171227
 
Custom Kits Company Inc