Label: SUN MOON STAR- menthol methyl salicylate patch

  • 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 July 13, 2011

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  • Active Ingredients

    Menthol 16%
    Methyl Salicylate 15%

  • Purpose

    External Analgesic

  • Uses

    For the temporary relief of minor pains and aches of muscles and joints  associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    • For external use only
    • avoid getting into the eyes or on mucus membranes.
     


  • When using this product

    • do not apply to wound or damaged skin.
    • do not bandage tightly
    • do not use otherwise than as directed

  • Stop use and ask a doctor if

    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
    • pain persists for more than 10 days
    • redness is present
    • conditions affect children under 12 years of age
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 12 years of age and older:
    • if necessary cut patch to size
    • remove protective backing and apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age:do not use, consult a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients Angelica root, Cang-zhu atractylodes rhizome, Chinese peony root, Dong Quai root, Fo-ti root,  Large leaf gentian root, Oleo gum resin, Notopterygium root, Phellodendron bark, Schizonepeta, and Skullcap root
  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label


  • INGREDIENTS AND APPEARANCE
    SUN MOON STAR   PAIN RELIEVING
    menthol methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63922-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol16 g
    Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate15 g
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN)  
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    GENTIANA MACROPHYLLA ROOT (UNII: 6559FC0U1B)  
    NOTOPTERYGIUM FRANCHETII ROOT (UNII: KRT28P6ITK)  
    PHELLODENDRON CHINENSIS BARK (UNII: 2866QMZ434)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63922-222-015 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2011
    Labeler - Kingsway Trading (780573205)
    Establishment
    NameAddressID/FEIBusiness Operations
    Licoman Herbal Research Lab Limited667017789manufacture
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