Label: DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5% ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 72934-5071-4 - Packager: Sincerus Florida, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 10, 2019
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- Directions for use
- Sincerus Florida, LLC. Adverse reactions
- Active, inactive
- 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% ointmentProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-5071 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIBUCAINE HYDROCHLORIDE (UNII: Z97702A5DG) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE HYDROCHLORIDE 0.5 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 1 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 15 g in 100 g PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) PRILOCAINE 5 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72934-5071-4 120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/11/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/11/2019 Labeler - Sincerus Florida, LLC (080105003) Establishment Name Address ID/FEI Business Operations Sincerus Florida, LLC 080105003 manufacture(72934-5071)
