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Name:Balsamo De Ubre Mascura
Manufacturer:Pharmalab Enterprises Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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.

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Drug Facts

Active Ingredient                                              Purpose

Methyl Salicylate 10.5 % ............................................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

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.

Directions

  • 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

Other Information

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

Enter section text here

Questions? call 1-800-560-5223

BalsamoDeUbre


BALSAMO DE UBRE   MASCURA
methyl salicylate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:14505-263
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 10.5 g  in 90 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (NATURAL)  
D&C YELLOW NO. 10  
MENTHOL  
METHYLPARABEN  
PARAFFIN  
PROPYLPARABEN  
PETROLATUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14505-263-03 90 g in 1 CONTAINER None
2 NDC:14505-263-05 150 g in 1 JAR None

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

Labeler - Pharmalab Enterprises Inc. (174401088)
Registrant - Pharmalab Enterprises Inc. (174401088)
Establishment
Name Address ID/FEI Operations
Pharmalab Enterprises Inc. 174401088 manufacture

Revised: 05/2011 Pharmalab Enterprises Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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