Drugplain

Lydexa 4.12% 41.2 mg/g

Lidocaine Hydrochloride · CREAM · PureTek Corporation

No Recall HistoryCurrently in Shortage
Plain English

Lydexa 4.12% is a cream containing lidocaine hydrochloride at 41.2 mg/g, taken topical. Manufactured by PureTek Corporation.

Key Facts

Brand Name
Lydexa 4.12%
Generic Name
Lidocaine Hydrochloride
NDC Code (Product)
59088-429
Manufacturer
PureTek Corporation
Strength
41.2 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Marketing Start
07/10/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

infusion site pain682 reports
nausea471 reports
drug ineffective435 reports
infusion site erythema422 reports
headache415 reports
dyspnoea409 reports
off label use400 reports
diarrhoea398 reports
fatigue350 reports
pain331 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 AND ADMINISTRATION Apply a thin film to the affected area two or three times daily or as directed by a physician.

Warnings

WARNINGS For external use only. Not for ophthalmic use.

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.

Adverse Reactions

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.

Frequently Asked Questions

What is Lydexa 4.12% used for?

Lydexa 4.12% contains Lidocaine Hydrochloride. It is a cream taken topical. Consult your doctor for specific uses.

Is Lydexa 4.12% a controlled substance?

Lydexa 4.12% is not classified as a controlled substance by the DEA.

What is the generic name for Lydexa 4.12%?

The generic name for Lydexa 4.12% is Lidocaine Hydrochloride. There are 12 other brand versions of Lidocaine Hydrochloride.

What is the NDC code for Lydexa 4.12% 41.2 mg/g?

The NDC (National Drug Code) for Lydexa 4.12% 41.2 mg/g is 59088-429, listed by PureTek Corporation.