701 DIEDA ZHENGTONG YAOGAO MEDICATED- camphor and menthol plaster 
MADISON ONE ACME INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients
Camphor 3.1%
Menthol 5%

Purpose
External Analgesic
External Analgesic

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

Warnings

For external use only

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

Do not use
■ on irritated or damaged skin
■ on wounds

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

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 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

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

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

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.

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

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

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)
image of can

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
image of box

701 DIEDA ZHENGTONG YAOGAO MEDICATED 
camphor and menthol plaster
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-620
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55614-620-021 in 1 CAN05/04/2020
11 in 1 POUCH
11 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:55614-620-0110 in 1 BOX05/04/2020
24 in 1 POUCH
21 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/04/2020
Labeler - MADISON ONE ACME INC (096196758)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-620)

Revised: 5/2020
Document Id: baa1a0a1-12b6-4c97-bf68-9d0776890a51
Set id: 115041ff-5046-4ca4-b54b-5652037e74bd
Version: 1
Effective Time: 20200504
 
MADISON ONE ACME INC