NEW TEROCIN- methyl salicylate, capsaicin, and menthol lotion 
Aidarex Pharmaceuticals 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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New Terocin Topical Pain Relief Lotion

Active ingredient

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

Purpose

Topical Analgesic

Uses

Temporarily relieves mild aches and pains of muscles or joints.

Warnings

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), Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate,

Propylene Glycol, Dimethyl Sulfone, Lavandula Angustifolia (Lavendar) Oil,

Lidocaine, 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 53217-0004-01

New Terocin

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

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Store in a dry, cool place

For Comments or Questions,

call 888-495-6075

IMAGE LABEL
NEW TEROCIN 
methyl salicylate, capsaicin, and menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53217-004(NDC:50488-1129)
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
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)  
LIDOCAINE (UNII: 98PI200987)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
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:53217-004-01120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/13/2013
Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 10/2013
Document Id: 2d60485d-d6e7-47d7-813d-0db3a3214e20
Set id: 00b96109-8ece-4531-8182-f5167e9f4632
Version: 1
Effective Time: 20131004
 
Aidarex Pharmaceuticals LLC