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SMART PRO

M J Winston International Ltd..
M J Winston International Ltd.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Topical Analgesic

SMART PRO 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

SMART PRO 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

SMART PRO

SMART PRO

Camphor, Menthol, Methyl Salicylate PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76092-101
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) 1.2 mg
MENTHOL 5.7 mg
methyl salicylate METHYL SALICYLATE 6.3 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
DIHYDROXYALUMINUM AMINOACETATE
EDETATE DISODIUM
GELATIN
GLYCERIN
KAOLIN
ALMASILATE
METHYLPARABEN
polysorbate 80
POLYVINYL ALCOHOL
water
SODIUM POLYACRYLATE (8000 MW)
SORBITAN SESQUIOLEATE
tartaric acid
titanium dioxide

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
part part348 2011-07-01


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