Label: TIANHE ZHUANGGU GAO- pain relieving plaster 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 May 25, 2010

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

  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 3.22%
    Menthol 1.39%
    Methyl salicylate 15.01%

  • PURPOSE

    Purpose

    External analgesic

    Uses For the temporary relief of minor aches and pains of muscles and joints due to:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • 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 tightly sealed
    • store at room temperature 15º to 30º C (59º to 86º F), away from sunlight
  • INACTIVE INGREDIENT

    Inactive ingredients dong quai root, ginger rhizome, lanolin, paraffin,
    petrolatum, rosin, and zinc oxide, on a rubberized fabric
    backing covered with protective paper.

  • 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

    TIANHE ZHANGGU GAO PAIN RELIEVING PLASTER NDC 68007-203-01 10 PLASTERS EACH PLASTER 2.27 IN X 4 IN (7 CM X 10 CM)IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    TIANHE ZHUANGGU GAO 
    pain relieving plaster plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68007-203
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.22 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.39 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE15.01 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68007-203-0110 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/25/2010
    Labeler - GUILIN TIANHE PHARMACEUTICAL CO LTD (528565427)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUILIN TIANHE PHARMACEUTICAL CO LTD528565427manufacture