Application Nr Approved Date Route Status External Links
ANDA076290 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Lidocaine 2.5% And Prilocaine 2.5% 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 2.5% And Prilocaine 2.5% 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 Effects Observed In Animal Studies (See Warnings ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Lidocaine LIDOCAINE ZINC20237
2. Prilocaine PRILOCAINE ZINC1530816

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