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NDC 28691-1300-02 BZK Antiseptic Towelette 0.13 g/100g Details

BZK Antiseptic Towelette 0.13 g/100g

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

Product Information

NDC	28691-1300
Product ID	28691-1300_0396a10e-46e6-4db8-847d-01cd35e08e93
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	BZK Antiseptic Towelette
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100g
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 28691-1300-02 (28691130002)

Pricing Information	N/A
NDC Package Code	28691-1300-2
Billing NDC	28691130002
Package	1 PACKET in 1 POUCH (28691-1300-2) / 1.8 g in 1 PACKET
Marketing Start Date	2020-04-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c17a9618-ad1e-4d8a-92d8-16fbfc77afe2 Details

Drug Facts

Active ingredient

Benzalkonium Chloride, 0.13

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin

Warnings

For external use only

Do not use in the eyes or apply over large areas of the body

Stop use if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Tear open packet, unfold and use as a washcloth

Other information

Store at room temperature: 15°-30°C (59° -86°F)

Inactive ingredients

Purified Water

SPL UNCLASSIFIED SECTION

Manufactured for

55 Walls Dr., Fairfield, CT 06824

www.FirstAidOnly.com

Made in Egypt

Packaging

INGREDIENTS AND APPEARANCE

BZK ANTISEPTIC TOWELETTE

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:28691-1300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:28691-1300-2	1 in 1 POUCH	04/17/2020
1		1.8 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/17/2020

Labeler - Pharmaplast SAE (644773319)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaplast SAE		644773319	manufacture(28691-1300)

Revised: 11/2020

Document Id: 0396a10e-46e6-4db8-847d-01cd35e08e93

Set id: c17a9618-ad1e-4d8a-92d8-16fbfc77afe2

Version: 3

Effective Time: 20201107