NEW TEROCIN- methyl salicylate, capsaicin, and menthol lotion lotion 
DIRECT RX

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NEW TEROCIN

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

Topical Analgesic

Temporarily relieves mild aches and pains of muscles or joints.

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.

Consult physician for children under 12.

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.

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.

578

NEW TEROCIN 
methyl salicylate, capsaicin, and menthol lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-578(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
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BORAGE OIL (UNII: F8XAG1755S)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
LIDOCAINE (UNII: 98PI200987)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-578-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/201810/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/27/201810/09/2023
Labeler - DIRECT RX (079254320)
Registrant - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320relabel(61919-578)

Revised: 10/2023
 
DIRECT RX