Label: BALSAMO DE VACA MASCURA- methyl salicylate ointment

  • NDC Code(s): 53145-403-03
  • Packager: Menper Distributors Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated April 15, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose
    Methyl Salicylate 10.5 % ............................................External Analgesic

  • PURPOSE

    Purpose

    External Analgesic

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    Warnings

    For external use only

  • Do not use

    • on wounds or damage skin
    • with a heating pad
    • on a child under 12 years of age 
    • over extensive areas of the body
    • on irritated skin
    • woth a bandage
  • Ask doctor before use if you have 

    redness over the affected area 

  • When using this product 

    • avoid contact with eyes or mucous membranes
    • do not bandage
  • Stop use and ask a doctor if 

    • condition worsens or symptoms persist for more than 7 days 
    • symptoms clear up and occur again within a few days 
    • excessive skin irritation occurs
  • 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 

    • Use only as directed 
    • adults and children 12 years and older apply to affected area not more tha 3 to 4 times daily
    • children under 12 years of age: ask a doctor

  • Other information

    • store at 15° to 25° C (59° to 77° F)
  • Inactive Ingredients:

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

  • Questions?

    call 1-800-60-5223 M-F 9 AM to 4 PM Eastern

  • PRINCIPAL DISPLAY PANEL

    BalsamoVaca

  • INGREDIENTS AND APPEARANCE
    BALSAMO DE VACA MASCURA 
    methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-403-0390 g in 1 CANISTER; Type 0: Not a Combination Product05/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/10/2011
    Labeler - Menper Distributors Inc. (101947166)
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