FDA Label for Rocainol Topical Analgesic
View Indications, Usage & Precautions
Rocainol Topical Analgesic Product Label
The following document was submitted to the FDA by the labeler of this product Compania Internacional De Comercio, S.a.p.i De C.v.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Rocainol Topical Analgesic Ointment
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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