Warm Patch Tong Gu Huo Luo Gao Patch
FDA Label NDC 87502-549

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory for the product Warm Patch Tong Gu Huo Luo Gao (NDC 87502-549). 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, purpose, uses, warning, when using this product, stop use if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Menthol    1.0%
Camphor       0.5%
Methyl Salicylate    2.0%

Purpose

Menthol    Topical Analgesic
Camphor         Topical Analgesic  
Methyl Salicylate      Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache  
  • Arthritis
  • Sprains
  • Strains
  • Bruises

Warning

For external use only.

● Avoid applying around the eyes and mucous membranes, or open wounds.
● Pregnant women, nursing mothers and any person with allergic reactions to drugs or cosmetics should consult a physician before use.
● Children should use this product under supervision.

When Using This Product

  • This product is suitable for use while reading, working, driving, exercising, at home, and traveling, etc.
  • It is advisable to use it for 4 hours.
  • Children under 2 years of age are prohibited from using this product.

Stop Use If

Skin irritation develops.

Keep Out Of Reach Of Children.

Directions

● Clean and dry the affected areas before application.
● Remove the protective film while applying the areas 1-2 times daily, cut into smaller size if desired. If necessary up to 3 sheets per day.
● Use only as directed. Firmly affix with adhesive tapes or elastic bandages around joint areas to secure the patch if needed.

Storage

Store at room temperature away from direct sunlight. Properly seal after opening.

Inactive Ingredients

SALIX BABYLONICA BARK, REHMANNIA GLUTINOSA ROOT, BLETILLA STRIATA WHOLE, STYPHNOLOBIUM JAPONICUM FLOWER BUD, ANGELICA DAHURICA WHOLE, MYRRH, FRANKINCENSE OIL, ANGELICA SINENSIS ROOT, OLIBANUM, PAEONIA VEITCHII ROOT, ROSIN, INCISED NOTOPTERYGIUM RHIZOME OR ROOT (NOTOPTERYGIUM FRANCHETII), MOMORDICA COCHINCHINENSIS SEED, LINDERA AGGREGATA LEAF, ZINC OXIDE, LICORICE, ROSE OIL, ANGELICA PUBESCENS ROOT, FD&C YELLOW NO. 5 ALUMINUM LAKE, SCROPHULARIA NINGPOENSIS ROOT, NEODYMIUM OXIDE, CHINESE RHUBARB ROOT, CINNAMON, SESAME OIL

Product Of Taiwan

Imported and distributed by Finemost Corporation, QualiHerb
13839 Bentley Place, Cerritos, CA 90703
[email protected]

Drug Facts Label

Image Description (Warmpatchtongguhuoluogao Image 01)

Image Description (Warmpatchtongguhuoluogao Image 01)

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