Hysan Hua Tuo Medicated Plaster
FDA Label NDC 63255-210

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hysan Pharmaceutical Co Ltd for the product Hysan Hua Tuo Medicated (NDC 63255-210). 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, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

Active Ingredients

Methyl Salicylate 1%

Otc - Purpose

Purpose

External Analgesic

Indications & Usage

Uses

Temporarily relieves minor aches and pains of muscles, stiffness around the neck and shoulders and joint pains due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

Warnings

  • external use only
  • use only as directed

Otc - Do Not Use

Do Not use

  • on opened wounds
  • on damaged skin
  • eczema
  • hairy surface of skin

Otc - Ask Doctor

Ask a doctor or pharmacist before use if you are

  • prone to allergic reactions from medicine and/or cosmetic
  • children under 12 years of age, and if you are pregnant or nursing a baby

Otc - When Using

When using this product

  • avoid contact with the eyes or mucous membranes
  • highly adhesive plaster may hurt skin upon removal

Otc - Stop Use

Stop use and ask a doctor if

  • a rash or irritation develops
  • condition worsens
  • symptoms persist for more than 7 days or clears up and occur again within a few days

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

  • adults and children 12 years and older, clean and dry the affected area, and apply to affected area not more than 3 to 4 times daily
  • if you have sensitive skin, try a small piece of the plaster on the arm for 60 minutes before first use. If rash, redness or itching results, discontinue use and consult a doctor

Other Safety Information

Other information

  • be stored below 28°C (82°F)
  • closed tightly after used

Inactive Ingredient

Inactive ingredients

menthol, sesame Oil

Otc - Questions

Questions or comments?

(626) 354 1819 M-F 9am to 5pm

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