Rocainol TOPICAL ANALGESIC

Dosage form: ointment
Ingredients: METHYL SALICYLATE 16g in 100g, MENTHOL 8g in 100g
Labeler: Compania Internacional de Comercio, S.A. de C.V.
NDC code: 54312-825

Medically reviewed by Drugs.com. Last updated on May 21, 2024.

Rocainol TOPICAL ANALGESIC OINTMENT

Drug Facts

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

Package Labeling:

ROCAINOL TOPICAL ANALGESIC
methyl salicylate, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54312-825
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (SALICYLIC ACID)	METHYL SALICYLATE	16 g in 100 g
MENTHOL (MENTHOL)	MENTHOL	8 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL
CETYL PHOSPHATE
WATER
MINERAL OIL
SODIUM BORATE
TROLAMINE
WHITE WAX
PETROLATUM

Packaging
#	Item Code	Package Description
1	NDC:54312-825-01	1 TUBE in 1 PACKAGE
1		45 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/30/2013

Labeler - Compania Internacional de Comercio, S.A. de C.V. (815039995)

Revised: 05/2019

Document Id: 8a36ce40-280a-78b5-e053-2a95a90a92ff

Set id: 827ec7b2-3d87-47e0-a47a-966b25732c32

Version: 4

Effective Time: 20190531

Compania Internacional de Comercio, S.A. de C.V.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer