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NDC 62332-0582-31

Lidocaine and Prilocaine 25 mg/g, 25 mg/g CREAM

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NDC
62332-0582-31
Generic Name
Lidocaine and Prilocaine
Brand Name
Lidocaine and Prilocaine
Strength
25 mg/g, 25 mg/g
Dosage Form
CREAM
Route
TOPICAL
Package Size
—
Labeler
Alembic Pharmaceuticals Inc.

FDA Drug Information

Indications & Usage

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 mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic…

Important Warnings

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 adverse effects (see Individualization of Dose ). Patients treated with class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide) should be under close surveillance and ECG m…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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