SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM- camphor, menthol, methyl salicylate patch 
M J Winston International Ltd..

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 ingredient

Purpose

Topical Analgesic

Uses

for temporary relief of minor pain associated with:

Warnings

When using this product

  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes and mucous membranes

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days
  • rash, itching, excessive skin irritation develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Butylated Hydroxy Toluene, Dihydroxy Aluminum Amino Acetate, Disodium Edetate, Gelatin, Glycerin, Kaolin, Magenesium Aluminometasilicate, Methyl Paraben, Polysorbate 80, Polyvinyl Alcohol, Purified Water, Sodium Polyacrylate, Sorbitan Sesquioleate, Tartaric Acid, Titanium Dioxide

Questions or Comments?

Distributed by

M J Winston International, Ltd.

San Dimas, California 91773

www.smartmed.us

Made in Korea

Package/Label Principal Display Panel

SMART PRO PATCH

WellPatch Pain Relief Patch
SMART PRO  MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM
camphor, menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76092-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.2 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.7 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE6.3 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
ALMASILATE (UNII: OZQ8O62H53)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76092-101-055 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2011
Labeler - M J Winston International Ltd.. (144927378)
Registrant - M J Winston International Ltd. (144927378)
Establishment
NameAddressID/FEIBusiness Operations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture

Revised: 6/2011
Document Id: fd8d9ad8-bfeb-49b9-90e7-37cf335a8cb5
Set id: ad334d10-9053-4c40-96a5-db7236564542
Version: 1
Effective Time: 20110620
 
M J Winston International Ltd..