FDA.reportPublic FDA data

Menticam Gel

Manufacturer
PureTek Corporation
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:22:24

Label at a glance#

ProductMenticam
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, CAMPHOR (SYNTHETIC)
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple bachache arthritis strains bruises sprains

Dosage and administration

do not use otherwise than directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor

Storage and handling

Store at controlled room temperature 20°-25°C (68°-77°C). Avoid excessive heat. Do not use if package is damaged. Keep out of reach of children.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%
Menthol 10%
Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Camphor - Topical analgesic
Menthol - Topical analgesic
Methyl Salicylate - Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple bachache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over affected area

When using this product

OTC - WHEN USING SECTION

  • use only as directed 
  • avoid contact with the eyes or mucous membranes 
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive skin irritation occurs

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use otherwise than directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 20°-25°C (68°-77°C).

Avoid excessive heat. Do not use if package is damaged. Keep out of reach of children.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Purified Water), Benzyl Alcohol, Carbomer, Polysorbate 80, Triethanolamine

How Supplied

HOW SUPPLIED SECTION

Menticam™ Gel is an anti-inflammatory anesthetic in a 3.5 oz/ 100 g tube.
NDC 59088-203-07

Menticam™ Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116730camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical GelPSN3
1116730camphor 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.3 MG/MG Topical GelSCD3
1116730camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-203-07Menticam100 g in 1 TUBEGEL1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-203MENTICAM (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [PURETEK CORPORATION]3Current NDC, 1 package rows20241004_081837a8-9669-be1f-e063-6394a90a9d20.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-203-07GM - Gram59088-2034b193e18-454d-4df0-9e03-7a609a96e10712024-01-04

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-20359088-203-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
TROLAMINE9O3K93S3TKIACT

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
MenticamCAMPHOR, MENTHOL, METHYL SALICYLATEPureTek Corporation081837a8-9669-be1f-e063-6394a90a9d202024-04-05WarningsExact identifier
ndc (package): 59088-203-07
ndc (product): 59088-203
ndc11 (package): 59088020307
spl id: 155ed276-9f40-62cd-e063-6294a90a8139
spl set id: 081837a8-9669-be1f-e063-6394a90a9d20

Reported adverse events (FAERS/openFDA)#

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