Label: 701 DIEDA ZHENGTONG YAOGAO MEDICATED- camphor and menthol plaster

  • NDC Code(s): 55614-620-01, 55614-620-02
  • Packager: MADISON ONE ACME INC
  • 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 May 4, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients
    Camphor 3.1%
    Menthol 5%

  • PURPOSE

    Purpose
    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

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you have
    ■ any concerns about using this product

  • WHEN USING

    When using this product
    ■ do not use otherwise than as directed
    ■ avoid contact with the eyes or mucous membranes
    ■ do not bandage tightly
    ■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

  • 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
    ■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
    ■ 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

  • ADVERSE REACTIONS

    Report any unexpected side effects from the use of this product to the FDA MedWatch Program

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 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: Cut to desired size, remove clear plastic film, and apply to affected area not more than 3 to 4 times daily.
    ■ Children under 3 years of age: Consult your physician.

  • 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
    Angelica dahurica root, butylated hydroxytoluene, cinnamon oil, ginger, lanolin, light mineral oil, methyl salicylate, natural latex rubber, nepeta tenuifolia flowering top, ocimum gratissimum leaf oil, petrolatum, polyisobutylene, reynoutria japonica root, rheum officinale root, rosin, safflower, saposhnikovia divaricata root, scutellaria baicalensis root, zanthoxylum nitidum root and zinc oxide on an elastic cloth backing and covered with a polyethylene film.

  • 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

    701 DIEDA ZHENGTONG YAOGAO MEDICATED PLASTER

    External Analgesic

    Camphor and Menthol

    NDC 55614-620-02

    1 Plaster - 3.93 x 157 inches (10 x 400 cm)
    image of can

  • PRINCIPAL DISPLAY PANEL

    701 DIEDA ZHENGTONG YAOGAO MEDICATED PLASTER

    External Analgesic

    Camphor and Menthol

    NDC 55614-620-01


    40 Plasters - Each Plaster 3.93 x 2.75 inches (10 x 7 cm)
    10 Pouches, 4 Plasters Per Pouch
    image of box

  • INGREDIENTS AND APPEARANCE
    701 DIEDA ZHENGTONG YAOGAO MEDICATED 
    camphor and menthol plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-620
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    GINGER (UNII: C5529G5JPQ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)  
    OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)  
    REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)  
    RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)  
    ROSIN (UNII: 88S87KL877)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55614-620-021 in 1 CAN05/04/2020
    11 in 1 POUCH
    11 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:55614-620-0110 in 1 BOX05/04/2020
    24 in 1 POUCH
    21 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/04/2020
    Labeler - MADISON ONE ACME INC (096196758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-620)