BALSAMO DE UBRE MASCURA- methyl salicylate ointment

Balsamo de Ubre by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient 

Methyl Salicylate 10.5 % ............................................Topical Analgesic

Uses

Topical Analgesic

Uses

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

Warnings

For external use only.

Avoid contact with the eyes.

Do not use otherwise than as directed

Do not use    with a heating pad

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

Stop use and ask a doctor immediately if

• pain persists for more than 7 days, redness is present, or in conditions affecting children under 12 years of age
• excessive irritation of skin develops
• condition worsens

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

• Adults and Children 12 years and older: apply generously and gently massage into painful area until the product disappears. Apply into affected area not more than 3 to 4 times daily
• Children under 12 years of age: ask a doctor

Other Information

Store at 15° C to 25° C (59° F to 77° F)

Inactive ingrediets 

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

Questions?

call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BALSAMO DE UBRE  MASCURA
methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-401
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 90 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-401-03	90 g in 1 CONTAINER; Type 0: Not a Combination Product	05/10/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/10/2011

Labeler - Menper Distributors Inc. (101947166)