HUA TUO MEDICATED PLASTER EXTRA STRENGTH- menthol camphor patch

Hua Tuo by

Drug Labeling and Warnings

Hua Tuo by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 3%
Camphor10%

Purpose

External Analgesic

External Analgesic

Uses

For the temporary relief of minor pains and aches of muscles and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

For external use only ■ Do not use ■ do not apply to wounds or damaged skin

■ discontinue use if excessive irritation of the skin develops ■ condition affect children uner 12 years of age

When using this product

■ Avoid contact with the eyes or mucus membranes ■ do not bandage tightly ■ Do not use otherwise than as directed

Stop use and ask a doctor if

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

■ redness is present

Keep out of reach of children

In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Directions

■ Adults and children 12 years of age and older remove the clear film backing

and apply to affected area not more than 3 to 4 times daily

■ Children under 12 years of age, consult a doctor before using.

■ Use caution when applying to hairy skin areas, highly adhesive plaster can hurt when removing.

Other Information

■ Store at 68-77ºF (20-25C)

Inactive Ingredients

angelica dahurica root, angelica pubescens root, boswellia sacra whole, carthamus tinctorius flower, cinnamon oil, clove oil, commiphora africana resin, drynaria fortunei root, eleutherococcus nodiflorus root bark, ginger, glechoma longituba whole, panax notoginseng root, saposhnikovia divaricata root, schizonepeta tenuifolia flowering top

Package Label

INGREDIENTS AND APPEARANCE

HUA TUO  MEDICATED PLASTER EXTRA STRENGTH
menthol camphor patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61821-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10 g

Inactive Ingredients
Ingredient Name	Strength
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)
BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)
CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)
CINNAMON OIL (UNII: E5GY4I6YCZ)
CLOVE OIL (UNII: 578389D6D0)
COMMIPHORA AFRICANA RESIN (UNII: W30OSW7A0S)
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)
GINGER (UNII: C5529G5JPQ)
GLECHOMA LONGITUBA WHOLE (UNII: 79GOE5902E)
PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61821-100-05	5 in 1 BOX; Type 0: Not a Combination Product	05/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2014

Labeler - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY		654032218	manufacture(61821-100)