Lidocaine Hydrochloride
Lidocaine 3% Cream
1c0abe84-5404-404e-b882-e910e4d43ffb
HUMAN PRESCRIPTION DRUG LABEL
Jan 30, 2024
Seton Pharmaceuticals
DUNS: 828898002
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
** Rx Only** NDC-13925-159-01 Net Wt. 1 oz. (28.35 g)
** Lidocaine 3% Cream**
** Topical Anesthetic**
** FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.**
** SETON PHARMACEUTICALS**
PREGNANCY SECTION
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.