Rx Item-Lidocaine-Prilocaine 2.5% Cream 30Gm By Padagis Gen Emla

NDC: 00574-2042-30
Lidocaine-Prilocaine
Brand
Emla
Manufacturer
PADAGIS
Strength
2.5-2.5%
Size
30.0 GM

SPL UNCLASSIFIED SECTION
Rx only
DESCRIPTION
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a ...
CLINICAL PHARMACOLOGY
Mechanism of Action: Lidocaine and Prilocaine Cream applied to intact skin under occlusive dressing, provides dermal analgesia by the release of lidocaine and prilocaine from the cream into ...
CLINICAL STUDIES
Lidocaine and Prilocaine Cream application in adults prior to IV cannulation or venipuncture was studied in 200 patients in four clinical studies in Europe. Application for at least 1 hour ...
INDICATIONS AND USAGE
Lidocaine and Prilocaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: • normal intact skin for local analgesia. • genital ...
CONTRAINDICATIONS
Lidocaine and Prilocaine Cream is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
WARNINGS
Application of Lidocaine and Prilocaine Cream to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine and prilocaine resulting in serious ...
PRECAUTIONS
General: Repeated doses of Lidocaine and Prilocaine Cream may increase blood levels of lidocaine and prilocaine. Lidocaine and Prilocaine Cream should be used with caution in patients who may be ...
ADVERSE REACTIONS
Localized Reactions: During or immediately after treatment with Lidocaine and Prilocaine Cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus ...
OVERDOSAGE
Peak blood levels following a 60 g application to 400 cm2 of intact skin for 3 hours are 0.05 to 0.16 µg/mL for lidocaine and 0.02 to 0.10 µg/mL for prilocaine. Toxic levels of lidocaine (>5 ...
DOSAGE AND ADMINISTRATION
Adult Patients-Intact Skin - A thick layer of Lidocaine and Prilocaine Cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION). Minor Dermal ...
HOW SUPPLIED
Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following: NDC No. Strength - Size - NDC 0574-2042-13 - 5 gram/tube - packed in 5. NDC 0574-2042-30 - 30 ...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0574-2042-30 - Rx Only - Lidocaine and Prilocaine Cream, USP 2.5%/2.5% FOR TOPICAL USE ONLY - 30 grams
INGREDIENTS AND APPEARANCE

Lidocaine-Prilocaine 2.5% Crea
Item No.:RX00574-2042-30 NDC No.: 00574-2042-30 00574-2042-30 00574-2042-30 00574-2042-30 UPC No. 3-05742-04230-2 Rx Item-Lidocaine-Prilocaine 2.5% Cream 30Gm

Lidocaine-Prilocaine 2.5% 2.5%
Item No.:RX867287/D, Item No. RX867287, 867287, NDC No.: 00168-0357-30, 00168-357-30, 0016835730, 00168035730, 0357-30, 035730 UPC No. 3-01680-35730-2, 301680-357302, 301680357302, Rx Item-Lidocaine-P

Lidocaine-Prilocaine 2.5% 2.5%
Item No.:RX867287/D, Item No. RX867287, 867287, NDC No.: 00168-0357-30, 00168-357-30, 0016835730, 00168035730, 0357-30, 035730 UPC No. 3-01680-35730-2, 301680-357302, 301680357302, Rx Item-Lidocaine-P

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RX ITEM-Lidocaine-Prilocaine 2.5% 2.5% C
NDC 00168-0357-30 UPC/GTIN No.3-01680-35730-2 Mfg.Part No.35730

Lidocaine-Prilocaine 2.5% 2.5% Cream 30G
BRAND: LIDOCAINE-PRILOCAINE NDC: 00168-0357-30,168035730 UPC: 3-01680-35730-2,301680357302

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