FDA Label for Tong Luo Qu Tong Gao

View Indications, Usage & Precautions

Tong Luo Qu Tong Gao Product Label

The following document was submitted to the FDA by the labeler of this product Henan Lingrui Pharmaceutical Co Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients
Camphor 5%
Menthol 3.4%


Otc - 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

Otc - 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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are

  • pregnant
  • taking other medications

Otc - 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

Otc - 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

Otc - 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 20° 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.


Otc - Questions



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


Package Label.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)


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