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

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LidoPro 4%

Methemoglobinemia

Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue lidocaine-containing products and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

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 20C - 25C (68F - 77F)

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

Principal Display Panel

NDC 53225-1022-1

Professional Use Only

LidoPro

Topical Pain Relief

Ointment & Applicator

Hands-Free Applicator

Reduced Scent

Deep Penetrating

Long Lasting

Soothing

Net WT 4 oz. (121 g)

LidoPro_Tube

LIDOPRO 
capsaicin, lidocaine, menthol, and methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:53225-1022-1121 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2014
2NDC:53225-1022-3300 in 1 CARTON01/01/201412/08/2023
2NDC:53225-1022-22.5 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:53225-1022-426 g in 1 TUBE; Type 0: Not a Combination Product01/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/01/2014
Labeler - Terrain Pharmaceuticals (078358750)

Revised: 12/2023
Document Id: 0c79cb67-2f8f-46b2-e063-6294a90aa1f2
Set id: 81000fe7-276c-455e-b758-f5b863cb98f1
Version: 25
Effective Time: 20231208
 
Terrain Pharmaceuticals