FDA.reportPublic FDA data

Merthiolate Tincture

Manufacturer
Germa Products, LLC
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:38:23

Label at a glance#

ProductMerthiolate Tincture First Aid Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

As a first aid to help prevent skin infection in n minor cuts n scrapes n burns Warnings For external use only

Dosage and administration

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 dry first.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

As a first aid to help prevent skin infection in n minor cuts n scrapes n burns
Warnings For external use only

Warnings

WARNINGS SECTION

For external use only
Ask a doctor before use. if you have deep or puncture wounds, animal bites or serious burns. When using this product. do not use in eyes or apply over large areas of the body. do not use longer than 1 week unless directed by a doctor.
Stop use and ask a doctor if condition persists or gets worse

Ask a Doctor before use if

OTC - ASK DOCTOR SECTION

If you have deep or puncture wounds, animal bites or serious burns.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 dry first.

Other Information

OTHER SAFETY INFORMATION

Product will stain skin and clothing. Store at room temperature 15º-30ºC (59º-85º).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Isopropyl alcohol, purified water, FD&C red # 40

Questions or Comments

OTC - QUESTIONS SECTION

1-305-256-1464

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MerthiolateMerthiolate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN8
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD8
1049254benzalkonium chloride 0.13 % Topical SolutionSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73635-1224-12023-05-09C16284748780-1f386c649-f636-0266-e053-dadaa90a7c1aMerthiolate Tincture
73635-1224-12023-05-09C16284748780-1f386c649-f636-0266-e053-dadaa90a7c1aMerthiolate Tincture
73635-1224-12023-01-30C16284748780-1f386c649-f636-0266-e053-dadaa90a7c1aMerthiolate Tincture
73635-1224-12023-01-30C16284748780-1f386c649-f636-0266-e053-dadaa90a7c1aMerthiolate Tincture

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73635-1224-1Merthiolate TinctureFirst Aid Antiseptic30 mL in 1 BOTTLE, WITH APPLICATORLIQUID308

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73635-122473635-1224-1

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
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
FD&C RED NO. 40WZB9127XOAIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-10-15full-release2026-06-01 00:25:51

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
Merthiolate Tincture First Aid AntisepticBENZALKONIUM CHLORIDE 0.13%Germa Products, LLCbf77c2f2-b975-7150-e053-2995a90ae1db2025-10-08WarningsExact identifier
ndc (package): 73635-1224-1
ndc (product): 73635-1224
ndc11 (package): 73635122401
spl id: 40a7584f-3b50-a0c7-e063-6294a90a586e
spl set id: bf77c2f2-b975-7150-e053-2995a90ae1db