Label: DIEDA FENGSHI GAO MEDICATED- camphor, menthol, methyl salicylate plaster

  • 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 November 14, 2019

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 8.3%
    Menthol 3.32%
    Methyl salicylate 13.84%

  • PURPOSE

    Purpose
    External analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains of muscles and joints
    due to: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

  • WARNINGS

    Warnings

    For external use only

    Allergy alert: This product contains natural rubber latex which may cause allergic reactions

  • DO NOT USE

    Do not use
    ■ on irritated or damaged skin ■ on wounds ■ otherwise than as directed

  • WHEN USING

    When using this product
    ■ avoid contact with the eyes or mucous membranes
    ■ do not bandage tightly
    ■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the plaster

  • STOP USE

    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
    ■ when using for pain of arthritis:
    ■ pain persists for more than 10 days ■ redness is present
    ■ in conditions affecting children under 12 years of age

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions
    ■ adults and children 3 years of age and older: remove the attached film from the plaster. Apply to affected area not more than 3 to 4 times daily
    ■ children under 3 years of age: consult your physician
    ■ refer to the above warnings; use otherwise than as directed may be dangerous

  • STORAGE AND HANDLING

    Other information
    ■ keep in a tightly closed container
    ■ store at 15º to 30º C (59º to 86º F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    African basil (Ocimum gratissimum L) herb oil, cinnamon oil, fang feng root, Formosan sweet gum (Liquidambar formosana Hance) Resin,
    fragrant angelica root extract, greater galangal root extract, ginger root extract, huo xue dan [Glechoma longituba (Nakai) Kuprian] aerial part,
    natural latex rubber, nux vomica (Strychnos nux-vomica L) seed, rosin, safflower flower, and schizonepeta (Schizonepeta tenuifolia Briq.) flowering
    aerial part on a cotton pad.

  • QUESTIONS


    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    ■ you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    EXTERNAL ANALGESIC

    NDC 61821-052-01

    DIEDA FENGSHI GAO MEDICATED PLASTER

    5 Plasters per Carton
    Each Plaster 7x10 cm (2.76 x 3.94 in)
    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    DIEDA FENGSHI GAO MEDICATED 
    camphor, menthol, methyl salicylate plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61821-052
    Route of AdministrationTOPICAL, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)8.3 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.32 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE13.84 g
    Inactive Ingredients
    Ingredient NameStrength
    OCIMUM GRATISSIMUM WHOLE (UNII: 7V3N80T4VS)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    LIQUIDAMBAR FORMOSANA RESIN (UNII: 597LBL467J)  
    GREATER GALANGAL (UNII: 7Y64R856MB)  
    GINGER (UNII: C5529G5JPQ)  
    GLECHOMA LONGITUBA TOP (UNII: D352074L9S)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919)  
    ROSIN (UNII: 88S87KL877)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61821-052-015 in 1 BOX; Type 0: Not a Combination Product06/17/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/17/2013
    Labeler - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218)
    Registrant - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY654032218manufacture(61821-052)
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