ANTISEPTIC BANDAGES- benzalkonium chloride dressing 
Pharmaplast SAE

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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Cure Aid Topical antimicrobial adhesive bandages

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

  • 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

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

Pharmaplast

Amria – Alexandria
Egypt
www.Pharmaplast-online.com

Packaging

label

ANTISEPTIC BANDAGES 
benzalkonium chloride dressing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28691-0010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Other Ingredients
Ingredient KindIngredient NameQuantity
Does not containNATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) 0 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:28691-0010-520 in 1 BOX10/07/2016
10.033 mg in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2NDC:28691-0010-630 in 1 BOX10/07/2016
20.033 mg in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
3NDC:28691-0010-740 in 1 BOX10/07/2016
30.033 mg in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2016
Labeler - Pharmaplast SAE (644773319)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaplast SAE644773319analysis(28691-0010) , label(28691-0010) , manufacture(28691-0010) , pack(28691-0010)

Revised: 11/2020
Document Id: ea625e81-1cbd-4987-8923-8cb7d5077401
Set id: ce7af871-a38d-4c51-8b0e-cb0eec5e8554
Version: 4
Effective Time: 20201107
 
Pharmaplast SAE