Active Ingredients
Menthol 3%
Methyl Salicylate 10%
Friccilicont
FDA Label NDC 53038-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Labocont Industrial for the product Friccilicont (NDC 53038-001). 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 ingredients, purpose, uses, 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
Counterirritant
Counterirritant
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with
simple backache
arthritis
strains
bruises
sprains
Warnings
For external use only. Avoid contact with the eyes.
When Using This Product
do not apply to wounds or damaged skin
do not bandage tightly
Stop Use And Ask A Doctor
condition worsens, or if symptoms persist for more than 7
days or clear up and occur again within a few days
redness is present
excessive irritation of the skin develops
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 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: Consult a physician.
Inactive Ingredients
stearic acid, turpentine, water
Package Label.Principal Display Panel
SHAKE
DO NOT DRINK
Ointment
Friccilicont
EXTERNAL ANALGESIC
EFFECTIVE AND REINFORCED
LABOCONT
INDUSTRIAL
Sto. Dgo., Rep. Dom.
LABORATORIOS, C. x A.
Made In Dominican Republic
Net Wt 10 oz (284 g)
MADE IN DOMINICAN REPUBLIC
MANUFACTURED FOR LABOCONT INDUSTRIAL, Km 19, Autopista las Americas, La Caleta. Sto. Dgo
DOMINICAN REPUBLIC TO REPORT A SERIOUS ADVERSE EVENT CONTACT 8109-756-7371
Friccilicont (Friccilicont)
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