Label: MASCURA LA VACA PLUS- methyl salicylate ointment

  • 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 14, 2021

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  • ACTIVE INGREDIENT

    Active ingredients   Purpose

    Methyl Salicylate 10.5%...............External analgesic

  • PURPOSE

    Purpose

    External analgesic

  • INDICATIONS & USAGE

    Uses

    • For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains and sprains.
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age
    • over extensive areas of the body
    • on irritated skin
    • with a bandage
  • ASK DOCTOR

    Ask a doctor before use if you have redness over the affected area.

  • WHEN USING

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or symptoms persists for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. If swallowed, induce vomiting and call a physician or contact a Posion Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • use only as directed
    • adults and children 12 years and older: apply to affected area not more than 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 INGREDIENT

    Inactive ingredients

    Camphor, D&c red #17, fragrance, menthol, methylparaben, paraffin wax, propylparaben, and white petrolatum.

  • QUESTIONS

    Questions: Call 1-800-560-5223 M-F 9AM to 4PM Eastern

  • PRINCIPAL DISPLAY PANEL

    vacared

  • INGREDIENTS AND APPEARANCE
    MASCURA LA VACA PLUS 
    methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-082
    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 RED NO. 17 (UNII: ND733RX3JN)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-082-0386 g in 1 JAR; Type 0: Not a Combination Product06/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/19/2019
    Labeler - MENPER DISTRIBUTORS, INC. (101947166)
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