Label: 701 DIEDA ZHENGTONG YAOGAO MEDICATED- camphor , menthol , methyl salicylate plaster

  • NDC Code(s): 61822-0046-1, 61822-0046-2
  • Packager: GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY
  • 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 13, 2019

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 3.1%
    Menthol 8%
    Methyl salicylate 10%

  • PURPOSE

    Purpose
    External analgesic
    External analgesic
    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
    with a heating pad
    if pregnant or nursing
    otherwise than as directed

  • WHEN USING

    When using this product
    avoid contact with the eyes or mucous membranes
    do not bandage tightly

  • 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
    Clean the affected area. Remove the paper film from the plaster.
    adults and children 12 years of age and older: apply one plaster to affected area not more than 3 to 4 times daily
    children under 12 years of age: do not use, 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 room temperature 15º to 30º C (59º to 86º F), away from sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients
    baikal skullcap (huang qin) root, bushy knotweed (polygonum cuspidatum sieb. et zucc.) (hu zhang) root and rhizome, Chinese rhubarb (da huang) root and rhizome, shiny bramble (zanthoxylum nitidum roxb.) D C (liang mian zhen) root, wingless cockroach (eupolyphaga sinenesis walker) (tu bie chong), on a rubberized fabric backing.

  • QUESTIONS

  • PRINCIPAL DISPLAY PANEL

    701 DIEDA ZHENGTONG YAOGAO MEDICATED PLASTER

    NDC 61822-0046-1

    External Analgesic

    1 Plaster – 3.9 x 157 inches (10 x 400 cm)

    Box1

    701 DIEDA ZHENGTONG YAOGAO MEDICATED PLASTER

    NDC 61822-0046-2

    External Analgesic

    10 Plasters – 4 x 2.8 inches (10 x 7 cm) each

    Box2

  • INGREDIENTS AND APPEARANCE
    701 DIEDA ZHENGTONG YAOGAO MEDICATED 
    camphor , menthol , methyl salicylate plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61822-0046
    Route of AdministrationTOPICAL, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g
    Inactive Ingredients
    Ingredient NameStrength
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    POLYGONUM CUSPIDATUM WHOLE (UNII: 1VDG5Y5HS6)  
    RHEUM TANGUTICUM WHOLE (UNII: QH89N6B02U)  
    ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)  
    EUPOLYPHAGA SINENSIS (UNII: 7USH1LF92M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61822-0046-11 in 1 CAN; Type 0: Not a Combination Product10/15/2001
    2NDC:61822-0046-210 in 1 BOX; Type 0: Not a Combination Product10/15/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/15/2001
    Labeler - GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY (530854970)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY530854970manufacture(61822-0046)