Huo Pao Tieh Ta Feng Shin Kao: Package Insert and Label Information

HUO PAO TIEH TA FENG SHIN KAO- levomenthol and camphor (synthetic) plaster
Dah Wei Biochemical Pharmaceutic International Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients:

each 5 g patch contains

L-Menthol 200 mg

Camphor 40 mg

Purpose:

External analgesic

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

Packaging

PLaster label
(click image for full-size original)

HUO PAO TIEH TA FENG SHIN KAO
l-menthol, camphor plaster
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62209-9266
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 200 mg in 5 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 40 mg in 5 g
Inactive Ingredients
Ingredient Name Strength
SESAME OIL
MYRRH
REHMANNIA GLUTINOSA WHOLE
ANGELICA DAHURICA WHOLE
ANGELICA SINENSIS WHOLE
PAEONIA LACTIFLORA WHOLE
NOTOPTERYGIUM INCISUM WHOLE
BLETILLA STRIATA WHOLE
LINDERA AGGREGATA WHOLE
GLYCYRRHIZA URALENSIS
ANGELICA PUBESCENS WHOLE
SCROPHULARIA NINGPOENSIS WHOLE
RHEUM PALMATUM WHOLE
CINNAMOMUM AROMATICUM WHOLE
MENTHA ARVENSIS WHOLE
Product Characteristics
Color green Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62209-9266-5 6 PATCH in 1 BAG contains a PATCH
1 5 g in 1 PATCH This package is contained within the BAG (62209-9266-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/06/2013
Labeler — Dah Wei Biochemical Pharmaceutic International Ltd. (657087313)
Establishment
Name Address ID/FEI Operations
Dah Wei Biochemical Pharmaceutic International Ltd. 657087313 manufacture (62209-9266)

Revised: 02/2014 Dah Wei Biochemical Pharmaceutic International Ltd.

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