NEW TEROCIN- methyl salicylate, capsaicin, and menthol lotion 
Advanced Rx Pharmacy of Tennessee, 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 Lotion

Methyl Salicylate 25%
Capsaicin 0.025%
Menthol 10%

Topical Analgesic

Uses

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.

Keep out of reach of children.

Consult physician for children under 12.

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.

As directed

Consult your physician

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Borago Officinalis (Borage) Seed Oil, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetyl Alcohol, Diazolidinyl Urea, Dimethyl Sulfone (DMSO), DMDM Hydantoin, Glyceryl Stearate, Lavandula Angustifolia (Lavender) Oil, Methyl Paraben, PEG-100 Stearate, Polysorbate-20, Polysorbate-60, Propyl Paraben, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum.

Bottle of:

120ml NDC: 80425-0256-01

label 1

NEW TEROCIN 
methyl salicylate, capsaicin, and menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0256(NDC:50488-1129)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
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
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
BORAGE SEED OIL (UNII: F8XAG1755S)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80425-0256-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/15/2023
Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Establishment
NameAddressID/FEIBusiness Operations
Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0256)

Revised: 2/2023
Document Id: f4bfc4a6-06f0-1f76-e053-2995a90a2b8f
Set id: f4bfc4a6-06ef-1f76-e053-2995a90a2b8f
Version: 1
Effective Time: 20230215
 
Advanced Rx Pharmacy of Tennessee, LLC