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NDC 28691-0010-07 Antiseptic Bandages 0.1 mg/100mg Details

Antiseptic Bandages 0.1 mg/100mg

Antiseptic Bandages is a TOPICAL DRESSING in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaplast SAE. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	28691-0010
Product ID	28691-0010_ea625e81-1cbd-4987-8923-8cb7d5077401
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Antiseptic Bandages
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	DRESSING
Route	TOPICAL
Active Ingredient Strength	0.1
Active Ingredient Units	mg/100mg
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Pharmaplast SAE
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 28691-0010-07 (28691001007)

Pricing Information	N/A
NDC Package Code	28691-0010-7
Billing NDC	28691001007
Package	40 PATCH in 1 BOX (28691-0010-7) / .033 mg in 1 PATCH
Marketing Start Date	2016-10-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ce7af871-a38d-4c51-8b0e-cb0eec5e8554 Details

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

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/07/2016

Labeler - Pharmaplast SAE (644773319)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaplast SAE		644773319	analysis(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