Label: TOP MEDICATED (camphor- natural, menthol,methyl salicylate oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 1, 2012

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  • Top Medicated Oil


  • Active Ingredients

    Camphor 10%

    Menthol 16%

    Methyl Salicylate 50%

  • Purpose

    External Analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints due to:

    • simple backache
    • strains
    • bruises
    • arthritis
    • sprains


  • Warnings

    For external use only


    Do not use

    • on wounds
    • on irritated or damaged skin
    • otherwise than as directed

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if:

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive irritation of the skin develops
    • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

    Keep out of reach of children

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

  • Directions

    • adults and children 3 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massaged as shown in the illustrations.
    • children under 3 years of age: consult your physician.
    • refer to the above warnings; use otherwise than as directed may be dangerous.
  • Other Information

    • store at 16 to 30 degrees C (16 to 86 degrees F)
    • preserve in tight container
  • Inactive Ingredients

    • Clove Oil
    • Lavender Oil
    • Turpentine Oil
  • Top Medicated Oil 1.7oz/50ml (67473-601-01)


    TopMedicatedOilA

    TopMedicatedOilB

  • INGREDIENTS AND APPEARANCE
    TOP MEDICATED 
    camphor (natural), menthol,methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50943-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)10 mL  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mL  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE50 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE OIL (UNII: 578389D6D0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50943-001-0150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34805/24/2012
    Labeler - A&A Medical Supplies (801197380)
    Registrant - Sheng Chun Tang Pharmaceutical Industrial Co., Ltd. (656347754)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheng Chun Tang Pharmaceutical Industrial Co., Ltd.656347754manufacture
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