DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5%- dibucaine hcl 0.5% / lidocaine 15% / phenylephrine hcl 1% / prilocaine 5% ointment
Sincerus Florida, LLC

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.

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DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5%

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

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 Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72934-5071
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72934-5071-4	120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/11/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/11/2019

Labeler - Sincerus Florida, LLC (080105003)

Name	Address	ID/FEI	Business Operations
Establishment
Sincerus Florida, LLC		080105003	manufacture(72934-5071)