Label: ASPI-RUB PAIN RELIEVER- methyl salicylate spray

  • 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 August 29, 2014

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  • Active Ingredients

    Methyl Salicylate   23.0%


  • Purpose

    External Analgesic


  • Inactive Ingredients

    Isopropyl Alcohol, Castor Oil, Pine Oil, Glycerin, Menthol, Peppermint Oil, Camphor, Polysorbate 20


  • WARNINGS

    For external use only.


    When using this product-

    use only as directed, do not bandage tightly or use with a heating pad - avoid contact with eye and mucous membranes do not apply to wounds or damaged, broken or irritated skin.


    If swallowed accidentally induce vomiting and call a physician. If redness is present, consult your physician immediately.


    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.


  • Directions

    Adults and children over the age of 12 years, apply generously to painful areas with a gentle circular massage 3 to 4 times daily. Children under 12 years of age consult a doctor.


  • Principal Display Panel

    NDC # 69151-100-01

    NEW AROMA!

    PAIN-RELIEVING RUB

    CLASSIC  ASPI-RUB

    PAIN RELIEVER

    RUB AWAY THE PAIN

    2 FL.oz (59 mL)

    FOR EXTERNAL USE ONLY



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  • INDICATIONS & USAGE

    Aspi-Rub® is an effective analgesic for temporary relief from minor pains, strains, back aches, muscular aches and cramps.


  • INGREDIENTS AND APPEARANCE
    ASPI-RUB  PAIN RELIEVER
    methyl salicylate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69151-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE23 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    WHITE PINE OIL (UNII: HA5CX6676U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69151-100-0159 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/29/2014
    Labeler - AspiRub Enterprises LLC (079478532)
    Establishment
    NameAddressID/FEIBusiness Operations
    AspiRub Enterprises LLC079478532manufacture(69151-100)
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