Label: MEDICATED GREEN OIL- menthol, methyl salicylate oil

  • 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 2, 2013

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  • Active Ingredient

    Menthol 16%

    Methyl salicylate 30%

    Purpose

    External Analgesic

  • Uses

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

    simple backache

    arthritis

    strains

    sprains

  • Warnings

    For external use only. Avoid contact with the eyes or mucus membranes.

    Do not use

    other than as directed.

    When using this product

    do not apply to wounds or damaged skin

    do not bandage tightly

    Stop use and ask a doctor

    if condition worsenes

    symptoms persist for more than 7 days or clear up and occur again within a few days.

    excessive irritation of the skin develops.

    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

    Adulst and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily. For children under 3 years of age, consult a doctor.

  • Other information

    keep in a cool and dry place.

    Store at an average temperature of 86degrees F (30C)

  • Inactive Ingredients

    Eucalyptus oil, fragrance, mineral oil

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: NATIONAL HEALTH CARE CORPORATION

    FOUNTAIN VALLEY, CA 92708 U.S.A.

    MADE IN HONG KONG

    TO REPORT A SERIOUS ADVERSE EVENT CONTACT

    1-213-618-6868

  • Product Label

    label

  • INGREDIENTS AND APPEARANCE
    MEDICATED GREEN OIL 
    menthol, methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55531-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55531-001-011 in 1 BOX
    124 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/02/2013
    Labeler - Allways Health-Care Corporation Limited (666241729)
    Registrant - Allways Health-Care Corporation Limited (666241729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allways Health-Care Corporation Limited666241729manufacture(55531-001)
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