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)

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Questions? call 1-800-560-5223

BalsamoDeUbre

BALSAMO DE UBRE   MASCURA
methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14505-263
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE10.5 g  in 90 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14505-263-0390 g in 1 CONTAINER
2NDC:14505-263-05150 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/10/2011
Labeler - Pharmalab Enterprises Inc. (174401088)
Registrant - Pharmalab Enterprises Inc. (174401088)
Establishment
NameAddressID/FEIBusiness Operations
Pharmalab Enterprises Inc.174401088manufacture

Revised: 5/2011
 
Pharmalab Enterprises Inc.