Terocin

Generic Name: methyl salicylate, capsaicin, menthol and lidocaine hydrochloride
Dosage Form: lotion

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.

Terocin Topical Pain Relief Lotion

Active ingredient

Methyl Salicylate 25%

Capsaicin 0.025%

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

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 Type HUMAN OTC DRUG Item Code (Source) NDC:50488-1231
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 25 g  in 100 mL
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.025 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL 10 g  in 100 mL
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 2.5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
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  
Packaging
# Item Code Package Description
1 NDC:50488-1231-1 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/01/2010
Labeler - Alexso Inc. (963338061)
Revised: 10/2010
 
Alexso Inc.



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