Lidocaine Hcl 5%
FDA Drug Information • Also known as: Lidocaine 5% Gel
- Brand Names
- Lidocaine 5% Gel
- Route
- TOPICAL
- Dosage Form
- GEL
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Lidocaine 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure: Chemical Structure
What Is Lidocaine Hcl 5% Used For?
INDICATIONS: For the temporary relief of pain.
Dosage and Administration
DOSAGE: Adults and children 12 years of age and older: apply a thin film to the affected areas(s) two or three times per day or as directed by a licensed healthcare practitioner.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS: During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.
Contraindications
CONTRAINDICATIONS: Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
Pregnancy and Breastfeeding
Use in Pregnancy: Teratogenic Effects; Pregnancy Category B. Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.
How Supplied
HOW SUPPLIED: Lidocaine 5% Gel is supplied in a 3 oz. (85 g) tube with CRC cap (NDC 59088-247-07). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20º-25ºC (68º-77º F) [see USP Controlled Room Temperature]. Protect from freezing.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.