LIDOPRO PATCH- lidocaine, menthol, methyl salicylate patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: • muscle soreness • strains • sprains • arthritis • simple backache • muscle stiffness • bruises • clean and dry affected area • open pouch and remove one patch containing medical adhesive backing • remove protective film from both patch and medical adhesive • apply one patch to the affected area of pain and leave in place for 8 to 12 hours • if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours • only use one patch at a time • do not use more than 2 patches per day • wash hands with soap and water after applying or removing patch • reseal pouch containing unused patches after each use Children under 18 years of age: Do not use As Directed

Authorization status:

OTC monograph not final

Summary of Product characteristics

LIDOPRO PATCH- LIDOCAINE, MENTHOL, METHYL SALICYLATE PATCH
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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LIDOPRO PATCH
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.
Lidocaine 4% - Topical Analgesic
Menthol 5% - Topical Analgesic
Methyl Salicylate 4% - Topical Analgesic
Topical Analgesic
USES
Temporarily relieves mild to moderate aches and pains of muscles and
joints associated
with:
• muscle soreness
• strains
• sprains
• arthritis
• simple backache
• muscle stiffness
• bruises
For external use only
Stomach bleeding warning
This product contains an NSAID, which may cause stomach bleeding. The
chance is
small, but higher if you
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take other drugs containing an NSAID (Aspirin