ZHUANGGU GAO PAIN RELIEVING- menthol plaster

Zhuanggu Gao Pain Relieving by

Drug Labeling and Warnings

Zhuanggu Gao Pain Relieving by is a Otc medication manufactured, distributed, or labeled by GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Menthol 3.5%

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 wounds
■ on irritated or damaged skin
■ if you are allergic to any ingredient in this product

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you have
■ any concerns about using this product

WHEN USING

When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
■ 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
■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
■ 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 childrento avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
■ adults and children 2 years of age and older: remove the protective film from the plaster. Apply to affected area not more than 3 to 4 times daily.
■ children under 2 years of age: consult your physician.

STORAGE AND HANDLING

Other information
■ keep plasters tightly closed in the zip-lock pouch
■ store at 15 to 30 C (59 to 86 F) in a dry place away from sunlight

INACTIVE INGREDIENT

Inactive ingredientsangelica sinensis root, cang-zhu atractylodes rhizome, fragrant angelica root, ginger rhizome, kaempferia galanga rhizome, lanolin, mineral oil, petrolatum, rosin, rubber, star anise fruit, styrene-isoprene, and zinc oxide on a fabric backing covered with protective paper film.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

Zhuanggu Gao Pain Relieving Plaster

NDC: 68007-402-01

10 Patches
Each Patch 2.75 in x 4 in (7 cm x 10 cm)
5 Patches per Pouch

INGREDIENTS AND APPEARANCE

ZHUANGGU GAO PAIN RELIEVING 
menthol plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68007-402
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	35 mg

Inactive Ingredients
Ingredient Name	Strength
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
GINGER (UNII: C5529G5JPQ)
KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
ROSIN (UNII: 88S87KL877)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
STAR ANISE FRUIT (UNII: CK15HA8438)
STYRENE (UNII: 44LJ2U959V)
ISOPRENE (UNII: 0A62964IBU)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68007-402-01	2 in 1 BOX	06/26/2022	10/31/2028
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/26/2022	10/31/2028

Labeler - GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD (528565427)

Establishment
Name	Address	ID/FEI	Business Operations
GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD		528565427	manufacture(68007-402)