HYSAN HUA TUO MEDICATED- menthol, methyl salicylate plaster

HYSAN HUA TUO MEDICATED PLASTER by

Drug Labeling and Warnings

HYSAN HUA TUO MEDICATED PLASTER by is a Otc medication manufactured, distributed, or labeled by HYSAN PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Menthol 5%

Methyl Salicylate 1%

PURPOSE

Purpose

External Analgesic

INDICATIONS & USAGE

Uses

Temporarily relieves minor aches and pains of muscles, stiffness around the neck and shoulders and joint pains due to:

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings

• external use only
• use only as directed

DO NOT USE

Do Not use

• on opened wounds
• on damaged skin
• eczema
• hairy surface of skin

ASK DOCTOR

Ask a doctor or pharmacist before use if you are

• prone to allergic reactions from medicine and/or cosmetic
• children under 12 years of age, and if you are pregnant or nursing a baby

WHEN USING

When using this product

• avoid contact with the eyes or mucous membranes
• highly adhesive plaster may hurt skin upon removal

STOP USE

Stop use and ask a doctor if

• a rash or irritation develops
• condition worsens
• symptoms persist for more than 7 days or clears up and occur again within a few days

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 12 years and older, clean and dry the affected area, and apply to affected area not more than 3 to 4 times daily
• if you have sensitive skin, try a small piece of the plaster on the arm for 60 minutes before first use. If rash, redness or itching results, discontinue use and consult a doctor

INACTIVE INGREDIENT

Inactive ingredients

Sesame Oil, Yellow Wax, Myrrh, Frankincense

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYSAN HUA TUO MEDICATED 
menthol, methyl salicylate plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63255-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	1 g

Inactive Ingredients
Ingredient Name	Strength
SESAME OIL (UNII: QX10HYY4QV)
YELLOW WAX (UNII: 2ZA36H0S2V)
MYRRH (UNII: JC71GJ1F3L)
FRANKINCENSE (UNII: R9XLF1R1WM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63255-001-01	5 in 1 BOX; Type 0: Not a Combination Product	12/04/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/04/2013

Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)

Establishment
Name	Address	ID/FEI	Business Operations
HYSAN PHARMACEUTICAL CO LTD		666427133	manufacture(63255-001)