BALSAMO DE VACA MASCURA- methyl salicylate ointment

Balsamo de Vaca Mascura by

Drug Labeling and Warnings

Balsamo de Vaca Mascura by is a Otc medication manufactured, distributed, or labeled by Menper Distributors Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose
Methyl Salicylate 10.5 % ............................................External Analgesic

PURPOSE

Purpose

External Analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

WARNINGS

Warnings

For external use only

Do not use

• on wounds or damage skin
• with a heating pad
• on a child under 12 years of age 
• over extensive areas of the body
• on irritated skin
• woth a bandage

Ask doctor before use if you have 

redness over the affected area 

When using this product 

• avoid contact with eyes or mucous membranes
• do not bandage

Stop use and ask a doctor if 

• condition worsens or symptoms persist for more than 7 days 
• symptoms clear up and occur again within a few days 
• excessive skin irritation occurs

if pregnant or breast-feeding

ask a health professional before use 

keep out of reach of children to avoid accidental poisoning.

If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

Directions 

• Use only as directed 
• adults and children 12 years and older apply to affected area not more tha 3 to 4 times daily
• children under 12 years of age: ask a doctor

Other information

• store at 15° to 25° C (59° to 77° F)

Inactive Ingredients:

Camphor, D&C yellow 10#, menthol, methylparaben, paraffin wax, propylparaben, white petrolatum.

Questions?

call 1-800-60-5223 M-F 9 AM to 4 PM Eastern

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BALSAMO DE VACA MASCURA 
methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-403-03	90 g in 1 CANISTER; Type 0: Not a Combination Product	05/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/10/2011

Labeler - Menper Distributors Inc. (101947166)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(53145-403)