BANDAGE- benzalkonium chloride swab 
Zhejiang Changdi Medical Co., Ltd.

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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Active Ingredients

Benzalkonium Chloride  0.12%

Purpose

Antiseptic

Use

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 dondition persists or gets worse .Do not use 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 Ingredient

None

label

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BANDAGE 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59194-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.0012 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
COTTON FIBER 
Packaging
#Item CodePackage Description
1NDC:59194-001-0124 in 1 CARTON
140 in 1 BOX
10.0459 mg in 1 POUCH
2NDC:59194-001-0218 in 1 CARTON
225 in 1 BOX
20.0459 mg in 1 POUCH
3NDC:59194-001-0318 in 1 CARTON
320 in 1 BOX
30.0459 mg in 1 POUCH
4NDC:59194-001-0418 in 1 CARTON
415 in 1 BOX
40.0459 mg in 1 POUCH
5NDC:59194-001-0524 in 1 CARTON
540 in 1 BOX
50.0459 mg in 1 POUCH
6NDC:59194-001-0624 in 1 CARTON
620 in 1 BOX
60.0459 mg in 1 POUCH
7NDC:59194-001-0724 in 1 CARTON
715 in 1 BOX
70.0459 mg in 1 POUCH
8NDC:59194-001-0824 in 1 CARTON
820 in 1 BOX
80.0459 mg in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2013
Labeler - Zhejiang Changdi Medical Co., Ltd. (528198683)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Changdi Medical Co., Ltd.528198683manufacture(59194-001)

Revised: 08/2013
Document Id: 38da479f-2a1a-4dc8-a5f3-419fc136fcbf
Set id: a36337b7-9429-47f4-9b6d-fb3c31d62ae1
Version: 3
Effective Time: 20130802
 
Zhejiang Changdi Medical Co., Ltd.