Application Nr Approved Date Route Status External Links
NDA022114 None Intradermal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lidocaine Hydrochloride Monohydrate Powder Intradermal Injection System Is Indicated For Use On Intact Skin To Provide Topical Local Analgesia Prior To Venipuncture Or Peripheral Intravenous Cannulation, In Children 3–18 Years Of Age. Lidocaine Hydrochloride Monohydrate Powder Intradermal Injection System Is Indicated For Use On Intact Skin To Provide Topical Local Analgesia Prior To Venipuncture In Adults. • Lidocaine Hydrochloride Monohydrate Powder Intradermal Injection System Is An Amide Local Anesthetic Indicated For Use On Intact Skin To Provide Local Analgesia Prior To Venipuncture Or Peripheral Intravenous Cannulation In Children 3–18 Years Of Age. ( 1 ) • Lidocaine Hydrochloride Monohydrate Powder Intradermal Injection System Is Indicated For Use On Intact Skin To Provide Topical Local Analgesia Prior To Venipuncture In Adults. ( 1 ) Important Limitations: • For Use On Intact Skin Only ( 1 , 2 ) • For External Use Only ( 5 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ZINC20237

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