Merthiolate

Manufacturer: Humco Holding Group, Inc.
Effective date: 2020-06-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:18:28

Label at a glance#

ProductMerthiolate

Active ingredientBENZALKONIUM CHLORIDE

Label structure16 sections

Indications and uses

first aid to help prevent skin infection in minor cuts, scrapes, burns and insect bites.

Dosage and administration

adults and children 2 years and older. clean the affected area. apply a small amount on the area 1 to 3 times daily. may be covered with a sterile bandage. if bandaged, let it dry first. children under 2 years of age, do not use, consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent skin infection in minor cuts, scrapes, burns and insect bites.

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites, serious burns.

When using this product

OTC - WHEN USING SECTION

do not get into eyes. If contact occurs, rinse eyes throughly with water. do not apply over large areas of the body. do not use over raw surfaces or blistered areas. do not use longer than 1 week unless directed by a doctor.

Stop use and aska doctor if

OTC - STOP USE SECTION

condition persists or gets worse. symptoms clear up and occur again within a few days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years and older. clean the affected area. apply a small amount on the area 1 to 3 times daily. may be covered with a sterile bandage. if bandaged, let it dry first. children under 2 years of age, do not use, consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol 10%, Acetone, FD&C Red No 4, purified water

Quality Choice Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QC

Premier Value

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PV

DDM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DDM

CVS Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVC

Vida Mia Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049254	benzalkonium chloride 0.13 % Topical Solution	PSN	3
1049254	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD	3
1049254	benzalkonium chloride 0.13 % Topical Solution	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0395-9122-92	2022-07-29	C162847	48780-1	e4f33bdf-a19f-d8a0-e053-dadaa90a6e4e	Private Label Merthiolate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-9122-92	Merthiolate	59 mL in 1 BOTTLE	LIQUID	59		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-9122	MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [HUMCO HOLDING GROUP, INC.]	3	Legacy NDC, 1 package rows	20200622_60645c63-bb74-49ea-e053-2a91aa0aeea6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Merthiolate
Benzalkonium Chloride
WATER
ALCOHOL
ACETONE
BENZALKONIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0395-9122	0395-9122-92

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
ACETONE	1364PS73AF	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB

Source Document#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a885346e-a8e7-c83e-e053-2a95a90aa083			60645c63-bb74-49ea-e053-2a91aa0aeea6	2020-06-20	Warnings	Exact identifier spl id: a885346e-a8e7-c83e-e053-2a95a90aa083 spl set id: 60645c63-bb74-49ea-e053-2a91aa0aeea6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.