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NDC 53329-0073-08 MicroKlenz Antimicrobial 0.1 mg/100mL Details

MicroKlenz Antimicrobial 0.1 mg/100mL

MicroKlenz Antimicrobial is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Medline Industries, LP. The primary component is BENZETHONIUM CHLORIDE.

Product Information

NDC	53329-0073
Product ID	53329-073_e9ac358e-c9bf-7091-e053-2a95a90a4609
Associated GPIs	92100022100910
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	MicroKlenz Antimicrobial
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzethonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.1
Active Ingredient Units	mg/100mL
Substance Name	BENZETHONIUM CHLORIDE
Labeler Name	Medline Industries, LP
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 53329-0073-08 (53329007308)

Pricing Information	N/A
NDC Package Code	53329-073-08
Billing NDC	53329007308
Package	236 mL in 1 BOTTLE, SPRAY (53329-073-08)
Marketing Start Date	2007-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 115dda08-709c-490a-9693-419b51441960 Details

Active ingredient

Benzethonium Chloride 0.1%

Purpose

First Aid Antiseptic

Uses

For first aid to help prevent infection in:

minor cuts
scrapes
burns

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

When using this product

do not use in or near the eyes
do not apply over large areas of the body or in large quantities
do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

condition worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

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

Directions

Clean affected area
Adjust nozzle and spray a small amount of this product on the area 1 to 3 times daily
If used as a wet compress, keep bandage wet with solution
If covered with a sterile bandage, let dry first.

Inactive ingredients

citric acid, cocamidopropyl betaine, disodium phosphate, phenoxyethanol, water

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in the USA with foreign and domestic materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: CRR108008

V2 RG22SAP

Package Label

INGREDIENTS AND APPEARANCE

MICROKLENZ ANTIMICROBIAL

benzethonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-073
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.1 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-073-08	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2007

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

Revised: 7/2022

Document Id: e9ac358e-c9bf-7091-e053-2a95a90a4609

Set id: 115dda08-709c-490a-9693-419b51441960

Version: 6

Effective Time: 20220731