Lidocainedrug info
lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream
What it is used for
Lidocaine and prilocaine cream USP, (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 are not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS ).
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 1, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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 melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol water partition ratio of 43 at pH 7.4 and has the following structure: Prilocaine, USP is chemically designated as propanamide, N -(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4 and has the following structure: Each gram of lidocaine and prilocaine cream, USP contains lidocaine 25 mg, prilocaine 25 mg, carbomer homopolymer Type B, polyoxyl 40 hydrogenated castor oil, purified water to 1 gram and sodium hydroxide to adjust to a pH approximating 9. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00. Image Image
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 1, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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