TEROCIN- methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion 
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

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.

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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.

Image of Label

Image of Label

TEROCIN 
methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35356-542(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 (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2.5 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:35356-542-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/201012/31/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/201012/31/2013
Labeler - Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC831276758relabel(35356-542)

Revised: 3/2018
Document Id: 423a716f-1b0e-4da2-b9b4-8348d95f0079
Set id: d9f3c4b8-7afb-4c47-911d-a1f7a1653ab3
Version: 3844
Effective Time: 20180320
 
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC