Tong Luo Qu Tong Gao
FDA Label NDC 42217-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Henan Lingrui Pharmaceutical Co Ltd for the product Tong Luo Qu Tong Gao (NDC 42217-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Image Of Box (Box)

Image Of Box (Box)

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