Active Ingredient
Menthol 1.4%
Cetilar Cream
FDA Label NDC 84797-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmanutra Usa Corp. for the product Cetilar (NDC 84797-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor, if pregnant or breast-feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Warnings
For external use only. Avoid contact with eyes
When Using This Product
- Do not bandage tightly
- do not apply to wounds or damage skin
Stop Use And Ask A Doctor
- 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
ask a health professional before use
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
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
The product must be stored at temperature between 50-86 °F (10-30°C), in a dry place away from light localized heat sources.
Inactive Ingredients
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.
* Please review the disclaimer below.
