Sunday, April 8, 2012

Terocin





Dosage Form: lotion
Terocin Topical Pain Relief Lotion

Active ingredient


Methyl Salicylate 25%


Capsaicin 0.025%


Menthol 10%


Lidocaine 2.50%



Purpose


Topical Analgesic



Uses


Temporarily relieves mild aches and pains of muscles or joints.



Warnings


  • Only for external use.

  • Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.

  • Consult your physician: if pain is persistent or worsens or if using any other topical pain products.

  • Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water.


Keep out of reach of children.


Consult physician for children under 12.



Directions


Wash and dry affected area. Shake bottle well before each use and gently rub


over area of pain. Use is not recommended more than four times a day. Wash


hands immediately afterwards to avoid contact with eyes.



Inactive ingredients


Water (Aqua), Propylene Glycol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate,


PEG-100 Stearate, Dimethyl Sulfone, Aloe Barbadensis Leaf Extract, Borago


Officinalis Seed Oil, Boswellia Serrata Extract, Xanthan Gum, Triethanolamine,


Methylparaben, Propylparaben, DMDM Hydantoin, Iodopropynyl Butylcarbamate.



Package/Label Principal Display Panel


NDC 50488-1231-1


Terocin


(terodoloricin)


Topical Pain


Relief Lotion


Long Lasting


Soothing Effect


120 ml (4 fl oz.)


Manufactured for: Alexso Inc.


Thousand Oaks, CA 91360


Made in U.S.A.


Patent Pending


Package Label










TEROCIN 
methyl salicylate, capsaicin, menthol and lidocaine hydrochloride  lotion










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)50488-1231
Route of AdministrationTOPICALDEA Schedule    

















Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (METHYL SALICYLATE)METHYL SALICYLATE25 g  in 100 mL
CAPSAICIN (CAPSAICIN)CAPSAICIN0.025 g  in 100 mL
MENTHOL (MENTHOL)MENTHOL10 g  in 100 mL
LIDOCAINE HYDROCHLORIDE (LIDOCAINE)LIDOCAINE HYDROCHLORIDE2.5 g  in 100 mL




































Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
CETYL ALCOHOL 
STEARIC ACID 
GLYCERYL MONOSTEARATE 
POLYOXYL 100 STEARATE 
DIMETHYL SULFONE 
ALOE VERA LEAF 
BORAGE OIL 
INDIAN FRANKINCENSE 
XANTHAN GUM 
TROLAMINE 
METHYLPARABEN 
PROPYLPARABEN 
DMDM HYDANTOIN 
IODOPROPYNYL BUTYLCARBAMATE 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
150488-1231-1120 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2010


Labeler - Alexso Inc. (963338061)
Revised: 10/2010Alexso Inc.



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