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NDC 71584-0103-01 BZK antiseptic towelette 1.3 mg/mL Details

BZK antiseptic towelette 1.3 mg/mL

BZK antiseptic towelette is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Guangdong Comfort Medical Products Co., Ltd.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	71584-0103
Product ID	71584-0103_eb48d1fe-0ad1-6b3d-e053-2a95a90a52d3
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	SWAB
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Guangdong Comfort Medical Products Co., Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71584-0103-01 (71584010301)

Pricing Information	N/A
NDC Package Code	71584-0103-1
Billing NDC	71584010301
Package	1.4 mL in 1 PACKET (71584-0103-1)
Marketing Start Date	2017-07-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 548cc932-c4ea-3360-e054-00144ff88e88 Details

INACTIVE INGREDIENTS

Water

DIRECTIONS

Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.

WARNINGS

WARNINGS

For external use only.

DO NOT USE, in the eyes. If this happens, rinse thoroughly with water.

STOP USE and ASK A DOCTOR: If irritation or redness develop and persists for more than 72 hours.

CAUTION: Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

USES

USES

Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water.

CAUTION: Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

PURPOSE

First Aid Antiseptic

ACTIVE INGREDIENT

Benzalkonium chloride 0.13%

Drug Facts

ACTIVE INGREDIENT

Benzalkonium chloride 0.13% PURPOSE

First Aid Antiseptic USES

Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water. WARNINGS

For external use only.

DO NOT USE, in the eyes. If this happens, rinse thoroughly with water.

STOP USE and ASK A DOCTOR: If irritation or redness develop and persists for more than 72 hours.

CAUTION: 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. Allow hands to dry without wiping. OTHER INFORMATION

Store at room temperature. INACTIVE INGREDIENTS

Water.

INGREDIENTS AND APPEARANCE

BZK ANTISEPTIC TOWELETTE

benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71584-0103
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:71584-0103-1	1.4 mL in 1 PACKET; Type 0: Not a Combination Product	07/17/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/17/2017

Labeler - Guangdong Comfort Medical Products Co., Ltd. (544507534)

Registrant - Guangdong Comfort Medical Products Co., Ltd. (544507534)

Revised: 10/2022

Document Id: eb48d1fe-0ad1-6b3d-e053-2a95a90a52d3

Set id: 548cc932-c4ea-3360-e054-00144ff88e88

Version: 6

Effective Time: 20221018