Terocin Topical Pain Relief Lotion

Terocin by

Drug Labeling and Warnings

Terocin by is a Otc medication manufactured, distributed, or labeled by Alexso Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEROCIN- methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion 
Alexso 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: 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

Package Label

TEROCIN 
methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50488-1231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) 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 HYDROCHLORIDE2.5 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)  
POLYOXYL 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: 50488-1231-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/201009/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/201009/30/2019
Labeler - Alexso Inc. (963338061)

Revised: 11/2019
Document Id: c63bc583-ea4e-4a01-ae71-a00bd5a5ea97
Set id: 85066887-44d0-4a4a-adee-670073e4b22c
Version: 2
Effective Time: 20191108
 
Alexso Inc.