Bruselix Gel
Lidocaine HCI 3.88% · Gel · Topical
Uses
INDICATIONS: For the temporary relief of pain.
Dosage and administration
DOSAGE: Apply a thin film to the affected area two or three times daily or as directed by a licensed healthcare practitioner.
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.
Precautions
PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Bruselix™ Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted. 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. Pediatric Use: Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.
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.
Description
DESCRIPTION: Bruselix™ Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Citric Acid, Ethylhexylglycerin, Glycerin, Hydroxyethylcellulose, PEG-4, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure: Label
How supplied
HOW SUPPLIED: Bruselix™ Gel is supplied in a 2 oz. (57 g) tube with CRC cap. (NDC 59088-233-05)
Storage
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
Label text from the FDA structured product label by PureTek Corporation (revised Apr 5, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Lidocaine Hydrochloride in 1 product
Bruselix Gel NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59088-233 | Lidocaine Hydrochloride 38.8 mg/g Gel | PureTek Corporation | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Bruselix Gel used for?
INDICATIONS: For the temporary relief of pain.
What are the side effects of Bruselix Gel?
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 Bruselix Gel?
Bruselix Gel is listed by 1 labeler in the FDA NDC directory, including PureTek Corporation.