FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%- fluocinolone acetonide 0.025% / lidocaine hcl monohydrate 1% gel
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.

----------

FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%

Directions for use

Sincerus Florida, LLC. Adverse reactions

Active, inactive

NDC 72934- 1083-3 FLUOCINOLONE ACETONIDE USP 0.025% / LIDOCAINE HCL MONOHYDRATE USP 1%. Gel 60 gm

FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%
fluocinolone acetonide 0.025% / lidocaine hcl monohydrate 1% gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72934-1083
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	1 g in 100 g
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)	FLUOCINOLONE ACETONIDE	0.025 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72934-1083-3	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/20/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/20/2019

Labeler - Sincerus Florida, LLC (080105003)

Name	Address	ID/FEI	Business Operations
Establishment
Sincerus Florida, LLC		080105003	manufacture(72934-1083)