Zhuanggu Shexiang Zhitonggao Pain Relieving Plaster
FDA Label NDC 51367-019

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by International Nature Nutraceuticals for the product Zhuanggu Shexiang Zhitonggao Pain Relieving Plaster (NDC 51367-019). 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 active ingredients, uses, warnings:, do not use, ask a doctor or pharmacist before use if you are:, stop use and ask a doctor if, directions, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Camphor-3.0%
Menthol- 2.9%

Methyl Salicylate- 10.4%

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings:

For External Use Only

Do Not Use

  • On wounds
  • On irritated or damaged skin
  • If the appearance of this product has changed
  • In excess of 12 hours
  • If known sensitivity this product

Ask A Doctor Or Pharmacist Before Use If You Are:

Pregnant, or taking other medications

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

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 the guidance of a doctor

Children under 2 years of age: do not use

Storage

Store at 15o C to 30o C (59o to 86o F)

Keep away from heat

Inactive Ingredients

Frankincense, Myrrh, Schizonepeta tenuifolia flowering top, Saposhnikovia divaricata root, Chinese Cinnamon, Atropa belladona, natural latex rubber, rosin, aconitum kusnezoffi root, aconitum carmichaelii root, strychons nux-vomica seed, clove, erodium stephanianum top, periploca sepium root bark

Package

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