Lidotral 3.88% Roll on LIDOCAINE HCI PURETEK CORPORATION FDA Approved Lidotral® 3.88% Roll on Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol Ceteth-20 Phosphate, Cyclopentasiloxane Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol Ethylhexylglycerin, Glyceryl Stearates, Phenoxyethanol, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure: Label
FunFoxMeds bottle
Route
TOPICAL
Package NDC

Drug Facts

Composition & Profile

Strengths
3.88 % 85 g
Treats Conditions
Indications For The Temporary Relief Of Pain And Itching Associated With Minor Burns Sunburn Minor Cuts Scrapes Insect Bites And Minor Skin Irritation

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
V13007Z41A
Packaging

HOW SUPPLIED Lidotral® 3.88% Roll on Gel is supplied in a 3 oz. (85 g) roll on bottle (NDC 59088-307-07).; Lidotral® 3.88% Roll on Gel Label

Package Descriptions
  • HOW SUPPLIED Lidotral® 3.88% Roll on Gel is supplied in a 3 oz. (85 g) roll on bottle (NDC 59088-307-07).
  • Lidotral® 3.88% Roll on Gel Label

Overview

Lidotral® 3.88% Roll on Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol Ceteth-20 Phosphate, Cyclopentasiloxane Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol Ethylhexylglycerin, Glyceryl Stearates, Phenoxyethanol, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure: Label

Indications & Usage

INDICATIONS For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.

Dosage & Administration

DOSAGE Adults and children 4 years of age and older: apply a thin film to the affected area(s) two or three times daily or as directed by a licensed healthcare practitioner. See insert for complete product information.

Warnings & Precautions
WARNINGS For external use only. Not for ophthalmic use.
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.

Storage & Handling

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing. Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873


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