Your browser does not support JavaScript! LORIS BZK ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE) SWAB [LERNAPHARM LORIS INC.]
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LORIS BZK ANTISEPTIC WIPES (benzalkonium chloride) swab
[LernaPharm Loris Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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

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LORIS BZK  ANTISEPTIC WIPES
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68356-126
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:68356-126-01100 in 1 BOX
1NDC:68356-126-022.6 g in 1 PACKET
2NDC:68356-126-042.6 g in 1 PACKET
3NDC:68356-126-033 in 1 PACKAGE
32.5 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/21/2012
Labeler - LernaPharm Loris Inc. (206940905)
Establishment
NameAddressID/FEIBusiness Operations
LernaPharm Loris Inc.206940905manufacture(68356-126), label(68356-126)

Revised: 05/2013
Document Id: be4a880c-5ad3-4848-81b2-32add237ae51
Set id: a448de7b-4d96-4d53-ae1a-0bd38a2fb4a2
Version: 8
Effective Time: 20130509
 
LernaPharm Loris Inc.

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