Label: DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5% ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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 10, 2019

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  • Directions for use

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  • Sincerus Florida, LLC. Adverse reactions

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  • Active, inactive

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  • NDC 72934-5071-3 DIBUCAINE HCL USP 0.5% / LIDOCAINE USP 15% / PHENYLEPHRINE HCL USP 1% / PRILOCAINE USP 5%. Ointment 120gm

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  • INGREDIENTS AND APPEARANCE
    DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5% 
    dibucaine hcl 0.5% / lidocaine 15% / phenylephrine hcl 1% / prilocaine 5% ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-5071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIBUCAINE HYDROCHLORIDE (UNII: Z97702A5DG) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE HYDROCHLORIDE0.5 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE15 g  in 100 g
    PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) PRILOCAINE5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-5071-4120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/11/2019
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003manufacture(72934-5071)