701 DIEDA ZHENGTONG YAOGAO MEDICATED- camphor and menthol plaster

701 DIEDA ZHENGTONG YAOGAO MEDICATED by

Drug Labeling and Warnings

701 DIEDA ZHENGTONG YAOGAO MEDICATED by is a Otc medication manufactured, distributed, or labeled by MADISON ONE ACME INC, Zhejiang Dingtai Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Camphor 3.1%
Menthol 5%

PURPOSE

Purpose
External Analgesic
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

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
■ do not use otherwise than as directed
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

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

ADVERSE REACTIONS

Report any unexpected side effects from the use of this product to the FDA MedWatch Program

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. 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: Cut to desired size, remove clear plastic film, and apply to affected area not more than 3 to 4 times daily.
■ Children under 3 years of age: Consult your physician.

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
Angelica dahurica root, butylated hydroxytoluene, cinnamon oil, ginger, lanolin, light mineral oil, methyl salicylate, natural latex rubber, nepeta tenuifolia flowering top, ocimum gratissimum leaf oil, petrolatum, polyisobutylene, reynoutria japonica root, rheum officinale root, rosin, safflower, saposhnikovia divaricata root, scutellaria baicalensis root, zanthoxylum nitidum root and zinc oxide on an elastic cloth backing and covered with a polyethylene film.

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

701 DIEDA ZHENGTONG YAOGAO MEDICATED PLASTER

External Analgesic

Camphor and Menthol

NDC: 55614-620-02

1 Plaster - 3.93 x 157 inches (10 x 400 cm)

PRINCIPAL DISPLAY PANEL

701 DIEDA ZHENGTONG YAOGAO MEDICATED PLASTER

External Analgesic

Camphor and Menthol

NDC: 55614-620-01

40 Plasters - Each Plaster 3.93 x 2.75 inches (10 x 7 cm)
10 Pouches, 4 Plasters Per Pouch

INGREDIENTS AND APPEARANCE

701 DIEDA ZHENGTONG YAOGAO MEDICATED 
camphor and menthol plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55614-620
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CINNAMON OIL (UNII: E5GY4I6YCZ)
GINGER (UNII: C5529G5JPQ)
LANOLIN (UNII: 7EV65EAW6H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
METHYL SALICYLATE (UNII: LAV5U5022Y)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)
OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV)
PETROLATUM (UNII: 4T6H12BN9U)
POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)
ROSIN (UNII: 88S87KL877)
SAFFLOWER (UNII: 4VBL71TY4Y)
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55614-620-02	1 in 1 CAN	05/04/2020
1		1 in 1 POUCH
1		1 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 55614-620-01	10 in 1 BOX	05/04/2020
2		4 in 1 POUCH
2		1 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 not final	part348	05/04/2020

Labeler - MADISON ONE ACME INC (096196758)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd		420598724	manufacture(55614-620)