FDA Label for Lidopro
View Indications, Usage & Precautions
Lidopro Product Label
The following document was submitted to the FDA by the labeler of this product Terrain Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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%
Lidocaine HCL 4%
Menthol 10%
Methyl Salicylate 27.5%
Purpose
Topical Analgesic
Topical Analgesic
Topical Analgesic
Topical Analgesic
Uses:
Temporarily relieves minor aches and muscles pains associated with:
- arthritis
- simple back pain
- strains
- muscle soreness
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:
- apply product directly to affected area
- product may be used as necessary, but should not be used more than four times per day.
- wash hands immediately afterwards
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 [email protected]
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)
* Please review the disclaimer below.