CORALITE ANTIBACTERIAL BANDAGE- benzalkonium chloride patch 
UNITED EXCHANGE CORP

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.

----------

Coralite ANTIBACTERIAL BANDAGE WITH NON STICK PAD

Coralite ANTIBACTERIAL BANDAGE WITH NON STICK PAD


Drug Facts

Active Ingredients

Benzalkonium Chloride 0.12%

Purpose

Antiseptic

Uses

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

Warnings

For external use only.

Stop use and consult a doctor if the condition persists or gets worse.

Do not use

  • longer than one week unless directed by a physician. In case of deep or puncture wounds,  animal bites, or serious burn, consult a physician.
  • longer than 1 week unless directed by a doctor.

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

Directions

Clean and dry the affected area. Apply a sterile bandage on the area 1 to 3 times daily.

Other Information

Not intended for use on delicate or sensitive skin.

Inactive Ingredients

none

Coralite ANTIBACTERIAL BANDAGE WITH NON STICK PAD 30 count (65923-001-00)

AntibacterialBandage
CORALITE ANTIBACTERIAL BANDAGE 
benzalkonium chloride patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-001-0030 in 1 PACKAGE02/19/201409/30/2020
10.048 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/19/201409/30/2020
Labeler - UNITED EXCHANGE CORP (840130579)
Establishment
NameAddressID/FEIBusiness Operations
Planet (Suzhou) Medical Products Co., Ltd.528194366manufacture(65923-001)

Revised: 9/2019
Document Id: 93628989-adbd-97a5-e053-2995a90ab7e4
Set id: 7736c2c9-8594-4669-98c8-0f028f455d2a
Version: 100
Effective Time: 20190925
 
UNITED EXCHANGE CORP