SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM- camphor, menthol, methyl salicylate patch

SMART PRO by

Drug Labeling and Warnings

SMART PRO by is a Otc medication manufactured, distributed, or labeled by M J Winston International Ltd.., M J Winston International Ltd., Sinsin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

• DL-Camphor 1.20 %
• L-Menthol 5.70 %
• Methyl Salicylate 6.30 %

Purpose

Topical Analgesic

Uses

for temporary relief of minor pain associated with:

• arthritis
• simple backache
• tendonitis
• muscle strains
• bruises

Warnings

• For external use only
• If pregnant or breast feeding, consult a healthcare professional.
• Allergy Alert: If you are allergic to any ingredients of this product, ask a doctor before use.

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

• Adults and children 12 years of age and older
• clean and dry affected
• remove patch from film
• apply to affected area not more than 3 to 4 times daily for 7 days
• Children under 12 years of age consult a doctor

Other information

• avoid storing product in direct sunlight
• protect product from excessive moisture.
  

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

INGREDIENTS AND APPEARANCE

SMART PRO  MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM
camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76092-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.2 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.7 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	6.3 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76092-101-05	5 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2011

Labeler - M J Winston International Ltd.. (144927378)

Registrant - M J Winston International Ltd. (144927378)

Establishment
Name	Address	ID/FEI	Business Operations
Sinsin Pharmaceutical Co., Ltd.		687867143	manufacture