Lidocaine HCl 4% Menthol 1%

Manufacturer
OPMX LLC
Effective date
2022-06-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:48

Label at a glance#

ProductLidocaine HCl 4% Menthol 1%
Active ingredientLIDOCAINE, MENTHOL
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Menthol 1%

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water triethanolamine, vitamin E

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period.

BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

Children under 12 years: ask a doctor

INDICATIONS & USAGE SECTION

temporary relieves minor pain

WARNINGS SECTION

For external use only

Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, for more than one week without consulting a doctor.

When using this product use only as directed. Read and follow all directions and warnings on this label, rare cases of serious burns have been reported with products of this type, do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated, avoid contact with eyes and mucous membranes, a transient burning sensation may occur upon application but generally disappears in several days.

Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children and pets.

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

OTC - PURPOSE SECTION

Topical anesthetic

Topical analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 69729-452-72 Calmadrazos CalmadrazosCalmadrazos

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-452-722025-01-30C16284748780-12cef2736-acd8-d83d-e063-dadaa90ab31fCalmaDrazos Lidocaine HCl 4% and Menthol 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-452-72Lidocaine HCl 4% Menthol 1%76.6 g in 1 PACKAGEOINTMENT76.63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-452LIDOCAINE HCL 4% MENTHOL 1% OINTMENT [OPMX LLC]3Legacy NDC, 1 package rows20220612_b9cf255a-6e36-8a75-e053-2995a90af5ea.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-45269729-452-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
e11cc0b1-b375-6f1f-e053-2995a90a1e40b9cf255a-6e36-8a75-e053-2995a90af5ea2022-06-10WarningsExact identifier
spl id: e11cc0b1-b375-6f1f-e053-2995a90a1e40
spl set id: b9cf255a-6e36-8a75-e053-2995a90af5ea

Reported adverse events (FAERS/openFDA)#

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