ROCAINOL TOPICAL ANALGESIC- methyl salicylate, menthol ointment

Rocainol TOPICAL ANALGESIC by

Drug Labeling and Warnings

Rocainol TOPICAL ANALGESIC by is a Otc medication manufactured, distributed, or labeled by Compania Internacional de Comercio, S.A.P.I de C.V., Compania Internacional de Comercio, S.A.P.I. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

ROCAINOL TOPICAL ANALGESIC 
methyl salicylate, menthol ointment

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	16 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PHOSPHATE (UNII: VT07D6X67O)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM BORATE (UNII: 91MBZ8H3QO)
TROLAMINE (UNII: 9O3K93S3TK)
WHITE WAX (UNII: 7G1J5DA97F)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54312-825-01	1 in 1 PACKAGE	05/30/2019
1		45 g in 1 TUBE; Type 0: Not a Combination Product

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)