Lidocaine 5% Gel LIDOCAINE HCL 5% PURETEK CORPORATION FDA Approved 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
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Route
TOPICAL
Package NDC

Drug Facts

Composition & Profile

Strengths
5 % 85 g
Treats Conditions
Indications For The Temporary Relief Of Pain

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
V13007Z41A
Packaging

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.; LABEL Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 label

Package Descriptions
  • 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.
  • LABEL Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 label

Overview

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

Indications & Usage

INDICATIONS: For the temporary relief of pain.

Dosage & 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.

Warnings & Precautions
WARNINGS: For external use only. Not for ophthalmic use. PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Lidocaine 5% Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.
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.

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.


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