ANTISEPTIC BANDAGES- benzalkonium chloride dressing

Antiseptic Bandages by

Drug Labeling and Warnings

Antiseptic Bandages by is a Otc medication manufactured, distributed, or labeled by Pharmaplast SAE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Benzalkonium Chloride 0.1%

Purpose

Topical antimicrobial adhesive bandage

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 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.

Inactive Ingredients

None

SPL UNCLASSIFIED SECTION

CURE-AID®

INTENDED USE:
Antimicrobial Adhesive Bandages are to be applied to the skin for topical application. The bandages help provide an antibacterial barrier for minor cuts and scrapes.

DIRECTIONS:
Apply bandages to clean, dry skin. Change daily or when pad becomes wet. Sterile unless wrapper is damaged or open.

WARNINGS:
FOR MEDICAL EMERGENCIES SEEK PROFESSIONAL HELP

GERM FIGHTING PROTECTION
Help prevent infection Safe for all minor cuts and scrapes Unique, long lasting adhesive Medicated non-stick pad

• Each strip has been sealed and sterilized for your protection.
• Be sure skin is clean and dry before applying. Change bandage as needed.
• Sterility guaranteed unless individual envelope has been opened or damaged.

Pharmaplast

Amria – Alexandria
Egypt
www.Pharmaplast-online.com

Packaging

INGREDIENTS AND APPEARANCE

ANTISEPTIC BANDAGES 
benzalkonium chloride dressing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28691-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 100 mg

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

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
Does not contain	NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)	0 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28691-0010-5	20 in 1 BOX	10/07/2016
1		0.033 mg in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2	NDC: 28691-0010-6	30 in 1 BOX	10/07/2016
2		0.033 mg in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
3	NDC: 28691-0010-7	40 in 1 BOX	10/07/2016
3		0.033 mg in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/07/2016

Labeler - Pharmaplast SAE (557735337)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaplast SAE		557735337	analysis(28691-0010) , label(28691-0010) , manufacture(28691-0010) , pack(28691-0010)