Label: FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1% gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 72934-1083-3 - Packager: Sincerus Florida, LLC
- 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 20, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
-
INGREDIENTS AND APPEARANCE
FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%
fluocinolone acetonide 0.025% / lidocaine hcl monohydrate 1% gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-1083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72934-1083-3 60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/20/2019 Labeler - Sincerus Florida, LLC (080105003) Establishment Name Address ID/FEI Business Operations Sincerus Florida, LLC 080105003 manufacture(72934-1083)
