EXTRA STRENGTH HUA TUO PAIN RELIEVING (CAMPHOR AND MENTHOL) PLASTER [ZHEJIANG DINGTAI PHARMACEUTICAL CO., LTD]

EXTRA STRENGTH HUA TUO PAIN RELIEVING (CAMPHOR AND MENTHOL) PLASTER [ZHEJIANG DINGTAI PHARMACEUTICAL CO., LTD]
PDF | XML

NDC 69070-307-01
Set ID 9850754b-ac94-4ec6-b75a-8096e5ac9456
Category HUMAN OTC DRUG LABEL
Packager Zhejiang Dingtai Pharmaceutical Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient
    Camphor 3.1%.
    Menthol 2.6%

  • 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

    ■ if you are allergic to any ingredient in this product

  • 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

    ■ 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)
    
■ 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
    ■ 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 2 years of age and older: remove the protective film from the plaster. Apply to affected area not more than 3 to 4 times daily.
    ■ children under 2 years of age: consult your physician

  • STORAGE AND HANDLING

    Other information
    ■ keep plasters tightly closed in the zip-lock pouch
    
■ store at 15 to 30 C (59 to 86 F) in a dry place away from sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients
    Ocimum gratissimum leaf oil, butylated hydroxytoluene, cinnamon oil, saposhnikovia divaricata root, angelica dahurica root, ginger, lanolin, natural latex rubber, petrolatum, rosin, safflower, nepeta tenuifolia flowering top, and zinc oxide on an elastic cloth and covered with a protective paper 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 numb

  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH HUA TUO PAIN RELIEVING PLASTERS

    EXTERNAL ANALGESIC

    NDC 69070-307-01

    5 Plasters
Each Plaster 7x10 cm (2.75 x 4 in)

    EASY TO USE PAIN RELIEF PATCHES

    An effective herbal patch for the relief of aches and pains from muscles, joints, backache, arthritis, strains, bruises and sprains.
    IMAGE OF BOX

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH HUA TUO PAIN RELIEVING 
    camphor and menthol plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69070-307
    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) MENTHOL2.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    GINGER (UNII: C5529G5JPQ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ROSIN (UNII: 88S87KL877)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69070-307-011 in 1 BOX04/09/2019
    15 in 1 POUCH
    11 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 finalpart34804/09/2019
    Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(69070-307)

Related Drugs