ROCAINOL TOPICAL ANALGESIC- methyl salicylate, menthol ointment 
Compania Internacional de Comercio, S.A.P.I de C.V.

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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:

LabelInner Package

ROCAINOL TOPICAL ANALGESIC 
methyl salicylate, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-825
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE16 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54312-825-011 in 1 PACKAGE05/30/2019
145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/30/2013
Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (822165213)
Establishment
NameAddressID/FEIBusiness Operations
Compania Internacional de Comercio, S.A.P.I. de C.V.822165213manufacture(54312-825)

Revised: 10/2023
Document Id: 08c1157e-e2d4-2809-e063-6394a90acf48
Set id: 827ec7b2-3d87-47e0-a47a-966b25732c32
Version: 8
Effective Time: 20231028
 
Compania Internacional de Comercio, S.A.P.I de C.V.