Label: TONG LUO QU TONG GAO- camphor and menthol poultice

  • 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 June 2, 2010

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

  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 5%
    Menthol 3.4%

  • PURPOSE

    Purposes

    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 wounds
    • on irritated or damaged skin
    • if the appearance of this product has changed
    • in excess of 12 hours
    • if you have known hypersensitivities to this product
    • otherwise than as directed
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • pregnant
    • taking other medications
  • WHEN USING

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly
    • supervise use by children
    • use caution if prone to allergic reactions
  • 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
    • 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. If swallowed, get medical help or contact a Poison
    Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older: Apply one or two plasters to affected area once a day. Remove after 12 hours.
    • children 2 to 12 years of age and adults with compromised health: Use only under the guidance of a doctor
    • children under 2 years of age: Do not use, consult a doctor

    Refer to the above warnings; use otherwise than as directed may be dangerous.

  • STORAGE AND HANDLING

    Other information

    • keep container tightly closed
    • store below 20º C (68E F) in a dry area
  • INACTIVE INGREDIENT

    Inactive ingredients Chinese rhubarb rhizome and root, cinnamon bark, clove,
    dimethyl sulfoxide, dong-quai root, ginger rhizome, greater galangal rhizome, green
    peppercorns, lanolin, long pepper (Piper longum L.) fruit, paraffin, petrolatum, rosin,
    safflower flowers, Sichuan lovage rhizome, Sichuan pepper [Zanthoxylum piperitum (L.)
    DC.] peel, and zinc oxide, on a rubberized fabric support with a paper backing.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

  • PRINCIPAL DISPLAY PANEL

    TONG LUO QU TONG GAO PAIN RELIEVING POULTICE NDC 44217-100-01 4 PLASTERS EACH PLASTER 2.75 IN X 3.94 IN (7 CM X 10 CM)IMAGE OF BOX

  • INGREDIENTS AND APPEARANCE
    TONG LUO QU TONG GAO 
    camphor and menthol poultice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42217-100
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.4 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42217-100-014 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/02/2010
    Labeler - HENAN LINGRUI PHARMACEUTICAL CO LTD (530021062)
    Establishment
    NameAddressID/FEIBusiness Operations
    HENAN LINGRUI PHARMACEUTICAL CO LTD530021062manufacture