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Name: Balsamo De Ubre Mascura Manufacturer: Pharmalab Enterprises Inc. Category: Over-the-counter (OTC) Marketed Drugs
BALSAMO DE UBRE MASCURA
methyl salicylate ointment Pharmalab Enterprises Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active Ingredient Purpose
Methyl Salicylate 10.5 % ............................................Topical Analgesic
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains
For external use only
Do not use otherwise than as directed
Do not use
with a heating pad
with a tight bandage
on eyes, mucous membranes, broken or irritated skin
over extensive areas of the body
on a child under 12 years of age
Stop use and ask a doctor immediately if
pain persists for more than 7 days, or redness is present, or in conditions affecting children under 12 years of age
excessive irritation of skin develops
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.
Adults and Children 12 years and older: apply generously and gently massage into painful area until the product disappears. Repeat 3 to 4 times daily
Children under 12 years of age: ask a doctor
Store at 15 C to 25 C (59 F to 77 F)
Questions? call 1-800-560-5223
BALSAMO DE UBRE
MASCURA methyl salicylate ointment
HUMAN OTC DRUG
Item Code (Source)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
10.5 g in 90 g
D&C YELLOW NO. 10
90 g in 1 CONTAINER
150 g in 1 JAR
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC monograph not final
Labeler - Pharmalab Enterprises Inc.
Registrant - Pharmalab Enterprises Inc. (174401088)
Pharmalab Enterprises Inc.
Revised: 05/2011 Pharmalab Enterprises Inc.