Label: MEDICATED OIL- menthol, methyl salicylate oil

  • Category: HUMAN OTC DRUG LABEL

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 5, 2018

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  • Active Ingredients

    Menthol     8%
    Methyl Salicylate     26%

  • Purpose

    Menthol      Topical Analgesic
    Methyl Salicylate      Topical Analgesic

  • Uses

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

  • Directions

    Adults and children 12 years of age and older: Apply to the affected area 3 to 4 times daily. Children under 12 years of age:  Do not use, consult a doctor.

  • Warning

    For External Use Only.

  • When Using This Product

    Use only as directed.
    Do not get into eyes or mucous membranes.
    Do not apply to wound or damaged skin.
    Do not bandage tightly.
    Pregnant or lactating women consult a doctor before using.

  • Stop Use and Ask a Doctor If

    Condition worsens.
    Symptoms persist for more than 7 days or clear up and occur again within a few days.
    People with allergic conditution consult a doctor before using.

  • Other Information

    Keep bottle tightly closed and store at temperature below 25°C (77°F).

  • Keep out of reach of children.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Manufactured by

    Luoyang Muchun Pharmaceutical Co, Ltd.

    Distributed by Magic Wand (Beijing) Trading Co, Ltd

    1501-1502, 15th F, Building 3, No. 3 Zhonghe Road, Fengtai District, Beijing 100070

    Made in China

  • Inactive Ingredients

    CLOVE OIL, EUCALYPTUS GLOBULUS LEAF, CINNAMON OIL, PARAFFIN, ROSE OIL, PEPPERMINT OIL

  • Drug Facts

    image description

  • INGREDIENTS AND APPEARANCE
    MEDICATED OIL 
    menthol, methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72323-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE26 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE OIL (UNII: 578389D6D0)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    ROSE OIL (UNII: WUB68Y35M7)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72323-001-301 in 1 BOX06/15/2018
    1NDC:72323-001-1010 mL in 1 BOTTLE, GLASS; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2018
    Labeler - Luoyang Muchun Pharmaceutical Co, Ltd (526916382)
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