TEROCIN- methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion 
Preferred Pharmaceuticals, Inc.

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%

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 68788-9496-1

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

Terocin Topical Pain Relief Lotion

Package Label

TEROCIN 
methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9496(NDC:50488-1231)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE25 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BORAGE OIL (UNII: F8XAG1755S)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9496-1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/20/2014
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9496)

Revised: 3/2014
Document Id: 1402d6fc-73e9-4702-a2e3-71485d37122f
Set id: 1402d6fc-73e9-4702-a2e3-71485d37122f
Version: 1
Effective Time: 20140325
 
Preferred Pharmaceuticals, Inc.