LIDODOSE- lidocaine hydrochloride gel

Lidodose by

Drug Labeling and Warnings

Lidodose by is a Otc medication manufactured, distributed, or labeled by Gensco Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Administration

Adults and children 2 years of age and older: Apply using a gloved hand. Swirl the applicator tip prior to removing swab from the pouch and apply to area 3-5 minutes prior to procedure not more than 4 times daily.

Children under 2 years of age: consult a physician.

Usage

Pain relief

Warning: for external use only.

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 LidoDose 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.

Avoid contact with eyes.

Stop use and consult a physician if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use in large quantities, particularly over raw surfaces or blistered areas.

DRUG INTERACTIONS

Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents:

• Class: Examples
• Nitrates/Nitrites: nitroglycerin, nitroprusside, nitric oxide, nitrous oxide
• Local anesthetics: benzocaine, lidocaine, bupivacaine, inepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine
• Antineoplastic agents: cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea
• Antibiotics: dapsone, sulfonamides, nitrofurantoin, para¬aminosalicylic acid
• Antimalarials: chloroquine, primaquine
• Anticonvulsants: phenytoin, sodium valproate, phenobarbital
• Other drugs: acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Storage

Store between 68 and 77 F (20 - 25 C), with allowed excursions between 59 and 86 F (15 - 30 C). Protect from freezing. (See USP Controlled Room Temperature).

PATIENT COUNSELING INFORMATION

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Active Ingredients:

Lidocaine Hydrochloride 3%

Purpose:

Anesthetic

Inactive Ingredients:

Aqua (Deionized Water), Carbomer, Isopropyl Alcohol, Petrolatum, Polysorbate-20, Triethanolamine

SPL UNCLASSIFIED SECTION

Please see product insert for additional information.

LIDO DOSE

INGREDIENTS AND APPEARANCE

LIDODOSE 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35781-0301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHANANOLAMINE PHENYLBENZIMIDAZOLE SULFONATE (UNII: TQA10H23WC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35781-0301-5	25 in 1 BOX	01/01/2018
1	NDC: 35781-0301-0	1 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 35781-0301-1	100 in 1 BOX	01/01/2018
2	NDC: 35781-0301-0	1 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2018

Labeler - Gensco Laboratories, LLC (831042325)

Establishment
Name	Address	ID/FEI	Business Operations
Gensco Laboratories, LLC		831042325	manufacture(35781-0301)