LEKON HERBAL PATCH GREEN- menthol,camphor patch 
Taiwan Three Mast Pharmaceutical Company Limited

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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Lekon Herbal Patch Green

ACTIVE INGREDIENTS:

Menthol 5.1%
Camphor 3%

PURPOSE

External analgesic

Keep out of reach of children.

USES:

Temporarily relieves minor aches and pains of muscles and joints due to: backache, arthritis, strains, bruises, sprains.

WARNING: for external use only
When using this product:
• avoid contact with the eyes or mucous membranes
• do not use on wounds or broken skin
Stop use and ask a doctor if:
• condition worsens
• excessive skin irritation develops
• nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
• symptoms persist for more than 7 days
If pregnant or breast-feeding, ask a doctor before use.

DIRECTIONS:

• Remove clear film and apply to sore area of skin.
   Use no more than 3times daily.
• Bandage will remain effective after 24 hours and will be even more effective if used after a bath. Do not apply on extremely hairy skin. Highly      adhesive plaster may hurt skin upon removal.
• For children under 12 years of age, consult a doctor before use.

OTHER INGREDIENTS:

Chuan Wu (Radix Aconiti Preparata), Cao Wu (Radix Aconiti Kusnezoffii Preparata), Di Huang (Radix Rehmanniae), Bai Lain (Radix Ampelopsis Japonicae), Bai ji(Rhizome Bletilla), Gui Zhi(Radix Angelicae Sinesis), Bai zhi(Radix Angelicae Dahuricae), Dang Gui(Radix Angelicae Sinesis), Chi Shao (Radix Rubrus Paeoniae Lactiflorae), Qiang Huo (Radix Et Rhizoma Notopterygii), Ku Shen(Radix Sophorae Flavescentis), Wu yao (Radix Linderae Strychnifoliae), Gan Cao (Radix Glycyrrhizae), Du Huo (Radix Angelicae Pubescentis), Xuan Shen(Radix Scrophulariae Ningpoensis), Da Huang (Radix Et Rhizoma Rhei), Liu Zhi (Ramulus Salicis Babylonicae), Dong Qing Oil (LLicis Pubescentis Radix).

OTHER INFORMATION:

• Keep unused plasters in pouch.
• Store at room temperature.

Packaging

image description

LEKON HERBAL PATCH GREEN 
menthol,camphor patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16597-4873
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACONITUM CARMICHAELII ROOT (UNII: XJ28061U1S)  
ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
AMPELOPSIS JAPONICA ROOT (UNII: O2672197TF)  
BLETILLA STRIATA BULB (UNII: 00T5SH6SEJ)  
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
NOTOPTERYGIUM FRANCHETII ROOT (UNII: KRT28P6ITK)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
LINDERA AGGREGATA ROOT (UNII: 517Q7XRT2T)  
LICORICE (UNII: 61ZBX54883)  
ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)  
SCROPHULARIA NINGPOENSIS ROOT (UNII: HC0FB6P85R)  
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)  
SALIX BABYLONICA WHOLE (UNII: 629X19YOW6)  
ILEX PUBESCENS ROOT (UNII: V5V22LFX73)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16597-4873-410 in 1 BAG
110 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/15/2014
Labeler - Taiwan Three Mast Pharmaceutical Company Limited (658305156)
Establishment
NameAddressID/FEIBusiness Operations
Taiwan Three Mast Pharmaceutical Company Limited658305156manufacture(16597-4873)

Revised: 12/2014
Document Id: 66006763-1fd4-4279-8a88-f49494a0ff89
Set id: 639105e5-3330-4cac-b904-b361ad3f6b76
Version: 1
Effective Time: 20141229
 
Taiwan Three Mast Pharmaceutical Company Limited