SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM

Dosage form: patch
Ingredients: CAMPHOR (SYNTHETIC) 1.2mg, MENTHOL 5.7mg, METHYL SALICYLATE 6.3mg
Labeler: M J Winston International Ltd..
NDC Code: 76092-101

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 Facts

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

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)1.2 mg
MENTHOL (MENTHOL) MENTHOL5.7 mg
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE6.3 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:76092-101-055 PATCH (PATCH) 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/FEIOperations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture

Revised: 06/2011
 
M J Winston International Ltd..

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)