BALSAMO DE UBRE MASCURA- methyl salicylate ointment 
Menper Distributors 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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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

Stop use and ask a doctor immediately if

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

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

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BALSAMO DE UBRE  MASCURA
methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) 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:53145-401-0390 g in 1 CONTAINER; Type 0: Not a Combination Product05/10/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/10/2011
Labeler - Menper Distributors Inc. (101947166)

Revised: 2/2022
Document Id: 83942e1c-27a6-401e-90c8-48d225852f87
Set id: fb7b3611-4dc7-49be-a1a7-c8d5534af18b
Version: 5
Effective Time: 20220218
 
Menper Distributors Inc.