Label: LIDOCAINE 15% / PHENYLEPHRINE HCL 0.25% / PRILOCAINE 5% ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 16, 2019

If you are a consumer or patient please visit this version.

  • Direcfor use

    sc

  • Sincerus Florida, LLC. Adverse reactions

    dws

  • Active, inactive

    ds

  • NDC 72934- 5138-4 LIDOCAINE USP 15% / PHENYLEPHRINE HCL USP 0.25% / PRILOCAINE USP 5%. Ointment 120gm

    cs

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 15% / PHENYLEPHRINE HCL 0.25% / PRILOCAINE 5% 
    lidocaine 15% / phenylephrine hcl 0.25% / prilocaine 5% ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-5138
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE15 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-5138-4120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/17/2019
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003manufacture(72934-5138)