Drug Details [pdf]

PARA-AID ANTIBACTERIAL BANDAGE- benzalkonium chloride swab swab
MCURE HEALTH SOLUTIONS INC.

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 Ingredient Purpose

Benzalkonium Chloride 0.12%...............................................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.

Keep out of reach of children. If swallowed, get medical help or contact a 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

Distributed by:

Mcure Health Solutions Inc.

20819 Currier Rd #200

City of Industry, CA 91789

Made in China

AP-0911

PARA-AID ANTIBACTERIAL BANDAGE
benzalkonium chloride swab swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52486-018
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 mg in 100 mg

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52486-018-01	0.048 mg in 1 POUCH; Type 0: Not a Combination Product	01/01/2018	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2018	01/01/2019

Labeler - MCURE HEALTH SOLUTIONS INC. (053034873)

Registrant - MCURE HEALTH SOLUTIONS INC. (053034873)

Revised: 10/2019

Document Id: 962b2c17-88a2-2b06-e053-2995a90a880f

Set id: 6239fbca-8655-86c3-e053-2a91aa0ac19d

Version: 2

Effective Time: 20191030

Drug Labeling and Warnings

Drug Details [pdf]