LIDOPRO- capsaicin, lidocaine, menthol, and methyl salicylate ointment 
Lake Erie Medical DBA Quality Care Products LLC

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LIDOPRO OINTMENT

Active Ingredient

Capsaicin 0.0325%

Purpose

Topical Analgesic

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Analgesic

Active Ingredient

Menthol 10%

Purpose

Topical Analgesic

Active Ingredient

Methyl Salicylate 27.5%

Purpose

Topical Analgesic

Uses:

Temporarily relieves minor aches and muscles pains associated with:

Warnings

For external use only

Do not use

  • on open wounds, cuts, damaged or infected skin
  • with bandage or a heating pad
  • if condition worsens or symptoms persists for more than 7 days
  • excessive skin irritation occurs

Ask a doctor before use if

  • you are allergic to any ingredients, PABA, aspirin products or sulfa

When using this product

  • avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

Store

at 20○C - 25○C (68○F - 77○F)

Directions

Adults 18 years and children 12 years and older:

Children 12 years or younger: ask a doctor

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.

For Questions or Comments

Please Email info@TerrainRX.com

Manufactured for
Terrain Pharmaceuticals
Reno, NV 89501

Made in the U.S.A.
Patent Pending

image description

LIDOPRO 
capsaicin, lidocaine, menthol, and methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-523(NDC:53225-1022)
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
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55700-523-01121 g in 1 BOTTLE; Type 0: Not a Combination Product05/19/201708/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/01/201408/31/2024
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758relabel(55700-523)

Revised: 12/2023
Document Id: 8f12e70f-d2a7-4012-b3b6-d4100bb4eeb0
Set id: 7d3113a3-aa2f-496b-b7cf-182aa7420ce0
Version: 5
Effective Time: 20231221
 
Lake Erie Medical DBA Quality Care Products LLC