Label: HUO PAO TIEH TA FENG SHIN KAO- l-menthol, camphor plaster
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Contains inactivated NDC Code(s)
NDC Code(s): 62209-9266-5 - Packager: Dah Wei Biochemical Pharmaceutic International Ltd.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 27, 2014
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- Official Label (Printer Friendly)
- Active Ingredients:
- Purpose:
- KEEP OUT OF REACH OF CHILDREN
- Uses:
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Warnings:
For external use only
Do not use:
■ On wounds
■ On infected or damaged skinWhen 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:
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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:
- Packaging
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INGREDIENTS AND APPEARANCE
HUO PAO TIEH TA FENG SHIN KAO
l-menthol, camphor plasterProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62209-9266 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 200 mg in 5 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 40 mg in 5 g Inactive Ingredients Ingredient Name Strength SESAME OIL (UNII: QX10HYY4QV) MYRRH (UNII: JC71GJ1F3L) REHMANNIA GLUTINOSA WHOLE (UNII: 37S3F886KQ) ANGELICA DAHURICA WHOLE (UNII: 667W6C5J4P) ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN) PAEONIA LACTIFLORA WHOLE (UNII: N44H57P7WG) NOTOPTERYGIUM INCISUM WHOLE (UNII: N8519Y5E6X) BLETILLA STRIATA WHOLE (UNII: WV2BSG60EW) LINDERA AGGREGATA WHOLE (UNII: 3ZU402829L) GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K) ANGELICA PUBESCENS WHOLE (UNII: SV5CN7O3MB) SCROPHULARIA NINGPOENSIS WHOLE (UNII: 2FW4P6X3W8) RHEUM PALMATUM WHOLE (UNII: 75P857ARCY) CINNAMOMUM AROMATICUM WHOLE (UNII: 9BPF21T8ZR) MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O) Product Characteristics Color green Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62209-9266-5 6 in 1 BAG 1 5 g in 1 PATCH 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 Business Operations Dah Wei Biochemical Pharmaceutic International Ltd. 657087313 manufacture(62209-9266)