Drug Facts
Composition & Profile
Identifiers & 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
- 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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