Lydexa 4.12%
Lidocaine Hydrochloride · Cream · Topical
Uses
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
Dosage and administration
Apply a thin film to the affected area two or three times daily or as directed by a physician.
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
For external use only. Not for ophthalmic use.
Precautions
If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Lydexa HCl 4.12% Cream 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. NURSINIG 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
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
Contains lidocaine HCl 4.12% 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 Lydexa 4.12% Cream contains Lidocaine HCl USP 4.12%. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic. image description
How supplied
Lydexa HCl 4.12% Cream 1 oz. (28.3 g) tube - NDC 59088-429-03
Storage
STORAGE AND HANDLING KEEP THIS AND ALL MEDICATIONS OUT OF 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
Label text from the FDA structured product label by PureTek Corporation (revised Mar 2, 2022). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Lidocaine Hydrochloride in 1 product
Lydexa 4.12% NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59088-429 | Lidocaine Hydrochloride 41.2 mg/g Cream | PureTek Corporation | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Lydexa 4.12% used for?
For the 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 Lydexa 4.12%?
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 Lydexa 4.12%?
Lydexa 4.12% is listed by 1 labeler in the FDA NDC directory, including PureTek Corporation.