LIDOPRO- capsaicin, lidocaine, menthol, and methyl salicylate ointment 
Preferred Pharmaceuticals Inc.

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.

----------

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:

Arthritis
Simple Backache
Muscle Sprains
Muscle Strains

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:

Clean and dry the affected area
Apply product directly to your skin, up to 4 times daily affected area
Wash hands immediately after use

Children Under 12 Years of Age: Consult physician

Other Information

Store in a cool, dry place with lid tightly closed
If the tamper-evident foil seal is not intact, do not use

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

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel

NDC 53225-1020-1

Preferred Pharmaceuticals Inc. NDC 68788-8314-1

LidoPro Topical Pain Relief Oint  Applicator
LIDOPRO 
capsaicin, lidocaine, menthol, and methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8314(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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.1 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:68788-8314-192 g in 1 BOTTLE; Type 0: Not a Combination Product07/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other07/08/2022
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8314)

Revised: 6/2024
Document Id: 60bc2e78-45b2-4b1c-8c7c-d5d96f3b7cf6
Set id: 3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd
Version: 2
Effective Time: 20240619
 
Preferred Pharmaceuticals Inc.