EXTRA STRENGTH HUA TUO MEDICATED PLASTER- camphor, menthol, methyl salicylate plaster

EXTRA STRENGTH HUA TUO MEDICATED PLASTER by

Drug Labeling and Warnings

EXTRA STRENGTH HUA TUO MEDICATED PLASTER 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 INGREDIENT

Active ingredients
Camphor 8.3%
Menthol 3.32%
Methyl salicylate 13.84%

PURPOSE

Purpose
External analgesic

INDICATIONS & USAGE

Uses
For the temporary relief of minor aches and pains of muscles and joints
due to: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

WARNINGS

Warnings

For external use only

Allergy alert: This product contains natural rubber latex which may cause allergic reactions

DO NOT USE

Do not use
■ on irritated or damaged skin ■ on wounds ■ otherwise than as directed

WHEN USING

When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the plaster

STOP USE

Stop use and ask a doctor if
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive irritation of the skin develops
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ when using for pain of arthritis:
■ pain persists for more than 10 days ■ redness is present
■ in conditions affecting children under 12 years of age

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental poisoning.
If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
■ adults and children 3 years of age and older: remove the attached film from the plaster. Apply to affected area not more than 3 to 4 times daily
■ children under 3 years of age: consult your physician
■ refer to the above warnings; use otherwise than as directed may be dangerous

STORAGE AND HANDLING

Other information
■ keep in a tightly closed container
■ store at 15º to 30º C (59º to 86º F)

INACTIVE INGREDIENT

Inactive ingredients
African basil (Ocimum gratissimum L) herb oil, cinnamon oil, fang feng root, Formosan sweet gum (Liquidambar formosana Hance) Resin,
fragrant angelica root extract, greater galangal root extract, ginger root extract, huo xue dan [Glechoma longituba (Nakai) Kuprian] aerial part,
natural latex rubber, nux vomica (Strychnos nux-vomica L) seed, rosin, safflower flower, and schizonepeta (Schizonepeta tenuifolia Briq.) flowering
aerial part on a cotton pad.

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number

PRINCIPAL DISPLAY PANEL

EXTERNAL ANALGESIC
NDC: 61821-051-01
EXTRA STRENGTH HUA TUO MEDICATED PLASTER
5 Plasters per Carton
Each Plaster 7x10 cm (2.76 x 3.94 in)

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH HUA TUO MEDICATED PLASTER  
camphor, menthol, methyl salicylate plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61821-051
Route of Administration	TOPICAL, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	8.3 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.32 g
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MENTHYL SALICYLATE, (+/-)-	13.84 g

Inactive Ingredients
Ingredient Name	Strength
OCIMUM GRATISSIMUM WHOLE (UNII: 7V3N80T4VS)
CINNAMON OIL (UNII: E5GY4I6YCZ)
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
LIQUIDAMBAR FORMOSANA RESIN (UNII: 597LBL467J)
GREATER GALANGAL (UNII: 7Y64R856MB)
GINGER (UNII: C5529G5JPQ)
GLECHOMA LONGITUBA TOP (UNII: D352074L9S)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919)
ROSIN (UNII: 88S87KL877)
SAFFLOWER (UNII: 4VBL71TY4Y)
SCHIZONEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61821-051-01	5 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/17/2013

Labeler - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218)

Registrant - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY		654032218	manufacture(61821-051)