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NDC 71310-0203-01 BZK Antiseptic Towelettes 1.3 mg/mL Details

BZK Antiseptic Towelettes 1.3 mg/mL

BZK Antiseptic Towelettes is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Taizhou Kangping Medical Science And Technology Co., Ltd.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	71310-0203
Product ID	71310-203_d4497ed7-6648-e175-e053-2a95a90a4dcb
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 Towelettes
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Taizhou Kangping Medical Science And Technology Co., Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	n/a

Package

Package Images

NDC 71310-0203-01 (71310020301)

Pricing Information	N/A
NDC Package Code	71310-203-01
Billing NDC	71310020301
Package	1 PATCH in 1 PACKET (71310-203-01) / 1.6 mL in 1 PATCH
Marketing Start Date	2020-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b1a5a8e2-e515-1365-e053-2995a90a9020 Details

Drug Facts

Active ingredients

Benzalkonium Chloride, 0.13%

Purpose

Antiseptic

Uses

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

Open packet, unfold and use as a washcloth.

Other information

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

Inactive ingredients

Purified Water

Package Labeling:

INGREDIENTS AND APPEARANCE

BZK ANTISEPTIC TOWELETTES

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71310-203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71310-203-01	1 in 1 PACKET	10/01/2020	10/30/2023
1		1.6 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/01/2020	10/30/2023

Labeler - Taizhou Kangping Medical Science And Technology Co., Ltd. (543429840)

Revised: 12/2021

Document Id: d4497ed7-6648-e175-e053-2a95a90a4dcb

Set id: b1a5a8e2-e515-1365-e053-2995a90a9020

Version: 2

Effective Time: 20211229