LIDOPRO- capsaicin, lidocaine, menthol, and methyl salicylate ointment 
Medsource Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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TP05-LidoPro 4% Ointment

Active Ingredient

Capsaicin 0.0325%

Purpose

Counterirritant

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Anesthetic

Active Ingredient

Menthol 10%

Purpose

Topical Analgesic

Active Ingredient

Methyl Salicylate 27.5%

Purpose

Counterirritant

Uses

For the temporary relief of joint pain and muscle pain associated with:

Warnings

For External Use Only

Do Not Use

  • On damaged, irritated, or infected skin
  • With a bandage or heating pad
  • If you are allergic to any ingredients in this product

When Using This Product:

Avoid contact with eyes and mucus membranes

Stop Use and Ask a Doctor If:

  • Conditions worsens
  • Excessive skin irritation develops
  • Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

If Pregnant orBreast-Feeding:

Ask a health professional before use.

Keep Out of Reach of Children:

If ingested seek medical help or contact a Poison Control Center immediately

Flammable:

Keep away from excessive heat or open flame

Directions

Adults and Children 12 Years of Age and Older:

Children Under 12 Years of Age:Consult physician

Other Information

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

Questions or Comments?

info@terrainrx.com

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232

LIDOPRO 
capsaicin, lidocaine, menthol, and methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-232(NDC:53225-1020)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.000325 g  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.04 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.275 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
INULIN (UNII: JOS53KRJ01)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHAMOMILE (UNII: FGL3685T2X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45865-232-0192 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product11/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/08/2022
Labeler - Medsource Pharmaceuticals (833685915)
Registrant - Westwood Laboratories, LLC (832280635)
Establishment
NameAddressID/FEIBusiness Operations
Medsource Pharmaceuticals833685915relabel(45865-232)

Revised: 3/2024
Document Id: 12dc27c8-5f9d-133d-e063-6394a90a7f41
Set id: 12daded2-c5f6-97cc-e063-6294a90aa6ee
Version: 1
Effective Time: 20240304
 
Medsource Pharmaceuticals