Lidorex
Lidocaine HCl · Gel · Topical
Uses
INDICATIONS: For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
Dosage and administration
DOSAGE AND ADMINISTRATION: Apply a thin film to the affected area two or three times daily or as directed by a physician.
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.
Warnings
WARNINGS: For external use only. Not for ophthalmic use. Keep out of reach of children.
Precautions
PRECAUTIONS: If irritation of sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Lidorex™ 2.8% Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine.
Side effects
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.
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.
Pediatric use
PEDIATRIC USE: Dosage in pediatric patients would be reduced commensurate with age, body weight, and physical condition.
Description
Contains Lidocaine HCl 2.8% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: INGREDIENTS: Each gram of Lidorex™ 2.8% Gel contains Lidocaine HCl USP 28 mg. Inactive Ingredients include: Aloe Barbadensis (Aloe Vera) Leaf Juice, Citric Acid, Hydroxyethylcellulose, Methylparaben, PEG-4, Propylene Glycol, Propylparaben, Purified Water. image description
Mechanism of action
MECHANISM OF ACTION: Lidorex™ 2.8% Gel releases Lidocaine from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby affecting local anesthetic action. A mild acidic vehicle lowers pH to increase protection against alkaline irritants and to provide a favorable environment for healing.
How supplied
HOW SUPPLIED: Lidorex™ 2.8% Gel 3.5 oz. (100 g) tube - NDC 59088-475-07 KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
Storage
STORAGE AND HANDLING: Store at 20°-25°C (68°-77° F) [see USP Controlled Room Temperature]. Protect from freezing.
Label text from the FDA structured product label by PureTek Corporation (revised Jan 11, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Lidocaine Hydrochloride in 1 product
Lidorex NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59088-475 | Lidocaine Hydrochloride 28 mg/g Gel | PureTek Corporation | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Lidorex used for?
INDICATIONS: For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
What are the side effects of Lidorex?
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. See the full label for the complete list.
Who makes Lidorex?
Lidorex is listed by 1 labeler in the FDA NDC directory, including PureTek Corporation.