Tianhe Zhuanggu Gao
FDA Label NDC 68007-203

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guilin Tianhe Pharmaceutical Co Ltd for the product Tianhe Zhuanggu Gao (NDC 68007-203). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, 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 3.22%
Menthol 1.39%
Methyl salicylate 15.01%

Otc - 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

Otc - 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

Otc - When Using

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

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
  • 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

Otc - 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 15° to 30° C (59° to 86° 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.

Otc - 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

Package Label.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 (Box)

Image Of Carton (Box)

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