ANTIBACTERIAL BANDAGES- benzalkonium chloride dressing 
Guangdong Comfort Medical Products 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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ANTIBACTERIAL BANDAGES

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 condition persists or gets worse.

Do not use longer than 1 week unless directed by a physician. In case of deep or puncture wounds, animal bites, or serious burn, consult a physician.

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

Keep out of reach of children

Keep out of reach of children. if swallowed get medical help or contact Poison control Center right away.

Dosage and administration

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

Label principal display panel

NDC 71584-0108-1

ANTIBACTERIAL BANDAGES

Drug Facts

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 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.

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 71584-0108-671584-0108-571584-0108-471584-0108-3equate-5equate-4equate-371584-0108-2equate-2equate-1label image

ANTIBACTERIAL BANDAGES 
benzalkonium chloride dressing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71584-0108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COTTON FIBER (UNII: 70LDW53ROO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71584-0108-10.5 g in 1 POUCH; Type 0: Not a Combination Product06/10/2018
2NDC:71584-0108-20.5 g in 1 POUCH; Type 0: Not a Combination Product10/05/2021
3NDC:71584-0108-30.5 g in 1 POUCH; Type 0: Not a Combination Product10/05/2021
4NDC:71584-0108-40.5 g in 1 POUCH; Type 0: Not a Combination Product10/05/2021
5NDC:71584-0108-50.5 g in 1 POUCH; Type 0: Not a Combination Product10/05/2021
6NDC:71584-0108-60.5 g in 1 POUCH; Type 0: Not a Combination Product10/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/2018
Labeler - Guangdong Comfort Medical Products Co., Ltd. (544507534)
Registrant - Guangdong Comfort Medical Products Co., Ltd. (544507534)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Comfort Medical Products Co., Ltd.544507534manufacture(71584-0108)

Revised: 3/2023
Document Id: f5dd8fa8-0b68-5a30-e053-2995a90ad194
Set id: 6e43b8b3-2d49-8f76-e053-2a91aa0affb0
Version: 6
Effective Time: 20230301
 
Guangdong Comfort Medical Products Co., Ltd.