Label: LEKON HERBAL PATCH GREEN- menthol,camphor patch
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Contains inactivated NDC Code(s)
NDC Code(s): 16597-4873-4 - Packager: Taiwan Three Mast Pharmaceutical Company Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 29, 2014
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENTS:
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- USES:
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WARNINGS
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:
- Packaging
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INGREDIENTS AND APPEARANCE
LEKON HERBAL PATCH GREEN
menthol,camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16597-4873 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.1 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 3 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16597-4873-4 10 in 1 BAG 1 10 g in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/15/2014 Labeler - Taiwan Three Mast Pharmaceutical Company Limited (658305156) Establishment Name Address ID/FEI Business Operations Taiwan Three Mast Pharmaceutical Company Limited 658305156 manufacture(16597-4873)
