Huo Pao Tieh Ta Feng Shin Kao
FDA Label NDC 62209-9266

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dah Wei Biochemical Pharmaceutic International Ltd. for the product Huo Pao Tieh Ta Feng Shin Kao (NDC 62209-9266). 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:, otc - keep out of reach of children, uses:, warnings:, dirctions:, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

each 5 g patch contains

L-Menthol      200 mg

Camphor        40 mg

Purpose:

External analgesic

Otc - Keep Out Of Reach Of Children

Keep out reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.

Uses:

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis strains, bruises and sprains.

Warnings:

For external use only

Do not use:
■ On wounds
■ On infected or damaged skin

When using this product:

■ Avoid contact with eyes or mucous membranes.
■ Do not bandage tightly.

Stop use and ask a doctor if:

■ Condition worsens
■ Symptom clear up and occur again within a few days.
■ Symptom persist for more than 7 days.
■ Nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ Excessive irritation of the skin develops

■ When using for pain of arthritis:
   ■ In conditions affecting children under 12 years of age
   ■ If redness is present
   ■ If pain persists for more than 10 days

Dirctions:

  • Adult & children 12 years of age and older
  • Remove the clear film backing and apply to the sore area of skin.
  • Use not more than three times daily
  • Bandage will remain effective after 24 hours and will be even more effective when using after bath.
  • Do not apply to extremely hairy skin
  • Highly adhesive bandage may hurt skin upon removal
  • For children under 12 years of age, do not use, consult a doctor

Other Information:

  • Keep container tightly closed, once opened, fold the opening and keep pressed closed with a clip
  • Store at room temperature

Inactive Ingredients:

Sesame Oil

Rehmania                      Rehmannia glutinosa

Fragrant Angelica           Angelica dahurica

Dong quai                     Angelica sinensis

Chinese peony               Poeonia lactiflora

Notopterygium               Notopterygium incisum

Bletilla                          Bletilla striata

Lindera                         Lindera aggregata

Chinese licorice              Glycyrrhiza uralensis

Pubescent angelica         Angelica pubescens

Scrophularia                  Scrophularia ningpoensis

Chinese rhubarb             Reheum palmatum

Cassia                          Cinnamomum aromaticum

Myrrha                         Commiphora myrrha

Chinese mint                 Mentha canadensis

U.S. Distributer:

EAST COAST
FARCEDES TRADING INC.
295 KENT AVE, BROOKLYN
N,Y.,11211

WEST COAST
KWOK HONG CHINESE HERBS, INC
3309 BALBOA STREET,
SAN FRANCISCO,CA 94121

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