Label: PAIN RELIEVING MUSFLEX (camphor- natural, menthol lotion

  • 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 January 11, 2013

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  • Pain Relieving Lotion MUSFLEX


  • Active Ingredients

    Camphor 5.6%

    Menthol 5.6%

  • Purpose

    External Analgesic

  • Uses

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

  • Warnings

    For external use only.

    Avoid contact with the eyes.

    Do not use

    • on wounds or damaged skin

    When using this product

    • do not bandage tightly

    Stop use and ask a doctor if

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

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of reach of children to prevent accidental poisoning.

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

  • Directions

    • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily
    • Children under 2 years of age: Consult a physician
  • Other Information

    • Store at room temperature under 85 degrees F (30 degrees C)
  • Inactive Ingredients

    Ethanol, Water, Ramulus Cinnamomi, Radix Notoginseng, Radix Angelicae Pubuscentis, Rhizoma Et Radix Pol Ygoni Cuspidati, Flos Carthami, Rhizoma Zedoariae

  • Manufactured By:

    Nan San (HK) Pharmaceutical Factory Limited

    Unit C1, 10/f, Hoi Bun

    Industrial Building, 6 Wing Yip Street,

    Kwun Tong, Hong Kong, China.

  • Distributed By:

    CHUNG KEE USA
    INTERNATIONAL INC
    BROOKLYN, NY 11238
  • Pain Relieving Lotion MUSFLEX


    MusflexOuterPackage

    InnerPackage

    DrugFacts

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING MUSFLEX  
    camphor (natural), menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55424-1398
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)56 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL56 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WATER (UNII: 059QF0KO0R)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    ANGELICA BISERRATA ROOT (UNII: OJ90180B22)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    ZEDOARY (UNII: 123C43G128)  
    POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55424-1398-880 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/09/2013
    Labeler - CHUNG KEE USA INTERNATIONAL INC (016224514)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nan San (HK) Pharmaceutical Factory Limited666458539manufacture(55424-1398)
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