Rocainol Topical Analgesic Ointment
FDA Label NDC 54312-825
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Compania Internacional De Comercio, S.a.p.i De C.v. for the product Rocainol Topical Analgesic (NDC 54312-825). 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 rocainol topical analgesic ointment, active ingredients, purpose, uses, warnings, do not use, do not apply, discontinue use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Methyl salicylate 16%
Menthol 8%
Purpose
External analgesic
Uses
Temporary relief of minor aches and pains associated with • arthritis • simple backache • bruises • sprains
Warnings
For External use only
Do Not Use
on pregnant women and children under 12 years of age unless directed by a doctor
Do Not Apply
to wounds or damaged skin
Do not bandage tightly
Discontinue Use
if excessive irritation of the skin develops
Keep This
and all drugs out of the reach of children.
If Condition Worsens,
or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor
Directions
Apply on affected area not more than 3 or 4 times daily. Adults and children 12 years of age and older. Children under 12 years of age: consult a doctor
Inactive Ingredients
Cetearyl alcohol, cetyl phosphate, distilled water, mineral oil, sodium borate, triethanolamine, white beeswax, white petrolatum
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