Cetilar

Manufacturer
PharmaNutra Usa Corp. | Biofarma SRL
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:55

Label at a glance#

ProductCetilar
Active ingredientMENTHOL
Label structure8 sections

Dosage and administration

Adults and children over 12 years: Apply to the affect area not more than 3 to 4 times daily After applying, wash hands with soap and water Children 12 years or younger, consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes

When using this product

OTC - WHEN USING SECTION

  • Do not bandage tightly
  • do not apply to wounds or damage skin

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

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

Adults and children over 12 years:

  • Apply to the affect area not more than 3 to 4 times daily
  • After applying, wash hands with soap and water

Children 12 years or younger, consult a doctor

Other Information

OTHER SAFETY INFORMATION

The product must be stored at temperature between 50-86 °F (10-30ºC), in a dry place away from light localized heat sources.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cetyl myristate, Glycerin, Cetyl alcohol, Glyceryl stearate, olea europea (olive ) oil unsaponifiables, cetyloleate, Butylene glycol, Caprylic capric triglyceride, prunus armeniaca (apricot) kenel oil, Beeswax, Phenoxyethanol, Triethanolamine, carbomer, fragrance, isopropyl myristate, ethylhexylglycerin, triticum vulgare (wheat) germ oil, BHT, tocopheryl acetate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2391332menthol 1.4 % Topical CreamPSN1
2391332menthol 14 MG/ML Topical CreamSCD1
2391332menthol 1.4 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84797-000-49Cetilar49 g in 1 TUBECREAM491
84797-000-49Cetilar1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84797-000CETILAR (MENTHOL 1.4%) CREAM [PHARMANUTRA USA CORP.]1Current NDC, 2 package rows20250213_2dd14bd4-b4e1-bc7d-e063-6394a90a1e59.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84797-00084797-000-49

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
CetilarMENTHOL 1.4%PharmaNutra Usa Corp.2dd14bd4-b4e1-bc7d-e063-6394a90a1e592025-02-04WarningsExact identifier
ndc (package): 84797-000-49
ndc (product): 84797-000
ndc11 (package): 84797000049
spl id: 2dd14e68-9b33-bad8-e063-6394a90a9fc1
spl set id: 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59

Reported adverse events (FAERS/openFDA)#

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