Merthiolate

Manufacturer
Pharma Nobis, LLC
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:33

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

QCQC

Premier Value

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVPV

DDM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DDMDDM

CVS Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVCCVC

Vida Mia Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VMVM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN2
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD2
1049254benzalkonium chloride 0.13 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-912-92Merthiolate59 mL in 1 BOTTLELIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-912MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231223_e42f727c-beaf-fe9d-e053-2995a90aafea.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82645-91282645-912-92

Ingredients#

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

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

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MerthiolateBENZALKONIUM CHLORIDEPharma Nobis, LLCe42f727c-beaf-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
ndc (package): 82645-912-92
ndc (product): 82645-912
ndc11 (package): 82645091292
spl id: 0d1cf782-d2a5-7dee-e063-6294a90a3604
spl set id: e42f727c-beaf-fe9d-e053-2995a90aafea

Reported adverse events (FAERS/openFDA)#

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