Label: SMARTRX NATURAL PAIN RELIEF SLEEVE ANKLE- methyl salicylate liquid

  • 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 December 27, 2013

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  • SmartRx Natural Pain Relief Sleeve ANKLE


  • Active ingredient

    Methyl Salicylate 10%

    Purpose

    External Analgesic (Counterirritant)

  • Use

    for the temporary relief of minor aches and pains of muscles and joints associated with • arthritis • strains • bruises • sprains.

  • Warnings

    For external use only. Avoid contact with the eyes.

    When using this product

    • Do not use otherwise than as directed.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.
    • Do not use in conjunction with liniments, balms or lotions.
    • Do not use on damaged or broken skin.

    Stop use and ask a doctor if

    • Redness is present.
    • Excessive irritation of skin develops.
    • Condition worsens, or if symptoms persist for more than 7 days.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children

    if swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Open pouch and remove. Pull woven sleeve containing external analgesic pads over ankle, positioning on either side of affected area.

    • Adults and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
    • Children under 3 years of age: Consult a physician.
  • Other information:

    • Store away from direct sunlight.
    • For your protection, this sleeve has been sealed in an aluminum pouch.
    • Do not use if tamper evident seal is missing, tampered, broken or destroyed.
  • Allergy warning:

    Contains Macadamia nut oil.

  • Inactive ingredients

    Macadamia nut oil, citronella oil, mandarin oil, coriander oil and rosemary oil.

  • Questions?:

    000-000-0000

  • SmartRx Natural Pain Relief Sleeve ANKLE 1 count (60589-001-00)

    Ankle Sleeve

  • INGREDIENTS AND APPEARANCE
    SMARTRX NATURAL PAIN RELIEF SLEEVE ANKLE 
    methyl salicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60589-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MACADAMIA OIL (UNII: 515610SU8C)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    MANDARIN OIL (UNII: NJO720F72R)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60589-001-001 in 1 BOX
    10.2 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/27/2013
    Labeler - Niche Brands, Inc. (079208100)
    Establishment
    NameAddressID/FEIBusiness Operations
    AB7 Industries381206077manufacture(60589-001)
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