ZHONG HUA FENG SHI DIE DA GAO EXTERNAL ANALGESIC PLASTER- menthol, methyl salicylate patch

Zhong Hua Feng Shi Die Da Gao External Analgesic Plaster by

Drug Labeling and Warnings

Zhong Hua Feng Shi Die Da Gao External Analgesic Plaster by is a Otc medication manufactured, distributed, or labeled by Big 5 Nutrition LLC, TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Analgesic

Drug Facts

• Active Ingredients: Purpose
• Menthol 4%: External Analgesic
• Methyl Salicylate 1%: External Analgesic

Uses

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

Warnings

For external use only

Do not use

● on wounds ● irritated or damaged skin ● sensitive skin
● with a heating pad ● if pregnant
● with, or as the same time as, other external analgesic products
● if allergic to aspirin or salicylates
● if allergic to any ingredients of this product

When using this product

● avoid contact with the eyes
● do not bandage tightly
● do not apply to wounds or damaged skin
● do not use more than 3 plasters a day
● do not use 1 hour before or after bathing

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
● rashes, itching or redness are present
● side effects occur.

If pregnant, ask a health professional before use.

Keep out of reach of childrento avoid accidental poisoning.

In case of overdose, get medical help or contact a Poison Control Center right
away.

Do not use otherwise than as directed.

Directions

● Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.
● Plaster will remain effective for 8 hours.
● Avoid using the same patch on the same area for more than 2 days.
● Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.
● Wet patch with warm water before removing from skin.
● Children under 12 years of age: Do not use or consult a doctor.

Other Information

●Store unused patch in the pouch
●Store at room temperature, 20 to 25°C(68 to 77°F)

lnactive ingredients

Chinese Clematidis Root & Rhizome, Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No. 2, FD&C Yellow No. 4, Zinc Oxide

Questions or Comments

Call:1-800-796-1888

Package Label

INGREDIENTS AND APPEARANCE

ZHONG HUA FENG SHI DIE DA GAO EXTERNAL ANALGESIC PLASTER 
menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82198-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.01 g  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)
YELLOW OB (UNII: QE535CBH7S)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
YELLOW WAX (UNII: 2ZA36H0S2V)
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)
SESAME OIL (UNII: QX10HYY4QV)
ZINC OXIDE (UNII: SOI2LOH54Z)
MYRRH (UNII: JC71GJ1F3L)
FRANKINCENSE (UNII: R9XLF1R1WM)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	green	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82198-0005-1	5 in 1 BAG	10/11/2021
1		1.7 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/11/2021

Labeler - Big 5 Nutrition LLC (114574559)

Establishment
Name	Address	ID/FEI	Business Operations
TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.		656348265	manufacture(82198-0005) , pack(82198-0005) , label(82198-0005)