ANTISEPTIC TOWELETTES- benzalkonium chloride cloth

Antiseptic Towelettes by

Drug Labeling and Warnings

Antiseptic Towelettes by is a Otc medication manufactured, distributed, or labeled by Custom Kits Company Inc, Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC TOWELETTES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68183-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68183-120-01	10 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	10/22/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/22/2015

Labeler - Custom Kits Company Inc (928643712)

Establishment
Name	Address	ID/FEI	Business Operations
Dynarex Corporation		008124539	manufacture(68183-120)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Kits Company Inc		928643712	repack(68183-120) , relabel(68183-120)