Label: TINNITUS RELINF PATCHES- camphor, borneol patch

  • NDC Code(s): 84445-007-01
  • Packager: Shenzhen Furuizhilian keji Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 17, 2024

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  • ACTIVE INGREDIENT

    Camphor 3%

    Borneol 4%

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only

  • DO NOT USE

    on damaged skin
    with a heating pad
    if you are allergic to any ingredients of this product

  • WHEN USING

    use only as directed
    avoid contact with the eyes, mucous membranes or rashes.
    do not bandage tightly

  • STOP USE

    ■ skin reactions such as redness, itching, rash, excessive irritation,burning sensation, swelling or blistering occur
    ■ symptoms persist for more than 7 days
    ■ symptoms clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and over:
    ■ clean and dry affected area
    ■ remove patch from film
    ■ apply to affected area not more than 3 to 4 times daily
    ■ remove patch from the skin after at most8-hour application
    Children under 12 years of age:
    consult a doctor

  • INACTIVE INGREDIENT

    Artemisia Argyi Leaf Extract, Scutellaria Baicalensis Extract, Poria Cocos Extract, Atractylodes Macrocephala Root Extract, Tangerine Peel, Magnolia Bark Extract

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TINNITUS RELINF PATCHES 
    camphor, borneol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84445-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL2.4 g  in 60 g
    CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-1.8 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    FU LING (UNII: XH37TWY5O4)  
    TANGERINE PEEL (UNII: JU3D414057)  
    MAGNOLIA OBOVATA BARK (UNII: SM9Z2LD5TK)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    ATRACTYLODES MACROCEPHALA ROOT (UNII: 08T3N29QJB)  
    ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84445-007-0160 g in 1 BOX; Type 0: Not a Combination Product07/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/17/2024
    Labeler - Shenzhen Furuizhilian keji Co., Ltd. (418598613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Furuizhilian keji Co., Ltd.418598613manufacture(84445-007)