LORIS BZK ANTISEPTIC WIPES- benzalkonium chloride swab

Loris BZK by

Drug Labeling and Warnings

Loris BZK by is a Otc medication manufactured, distributed, or labeled by LernaPharm Loris Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium chloride, 0.13% v/v

Purpose

First Aid Antiseptic

Uses

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Warnings

For External Use Only

• Do not use in the eyes or apply over large areas of the body.
• In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
• Stop use and consult a doctor if the condition persists or gets worse.
• Do not use for longer than 1 week unless directed by a doctor.
  

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

Directions

• Tear open pouch and use as part of your daily cleansing routine.
• Clean the affected area.
• Apply this product on the area 1 to 3 times daily.
• May be covered with a sterile bandage.
• If bandaged, let dry first.

Other Information

Store at room temperature between 59-86oF (15-30oC). If contact with eyes occurs, flush eyes with water.

Inactive Ingredients

Purified water

Questions or comments?

Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LORIS BZK  ANTISEPTIC WIPES
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68356-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68356-126-02	2.6 g in 1 PACKET; Type 0: Not a Combination Product	11/21/2012
2	NDC: 68356-126-04	2.6 g in 1 PACKET; Type 0: Not a Combination Product	11/21/2012
3	NDC: 68356-126-01	100 in 1 BOX	11/21/2012
3		2.6 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 68356-126-03	3 in 1 PACKAGE	11/21/2012
4		2.5 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/21/2012

Labeler - LernaPharm Loris Inc. (206940905)

Establishment
Name	Address	ID/FEI	Business Operations
LernaPharm Loris Inc.		206940905	manufacture(68356-126) , label(68356-126)