NDC 72934-1083

FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%

Fluocinolone Acetonide 0.025% / Lidocaine Hcl Monohydrate 1%

FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1% is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Lidocaine Hydrochloride; Fluocinolone Acetonide.

Product ID72934-1083_8957cf62-ea52-3447-e053-2a95a90a536a
NDC72934-1083
Product TypeHuman Prescription Drug
Proprietary NameFLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%
Generic NameFluocinolone Acetonide 0.025% / Lidocaine Hcl Monohydrate 1%
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-05-20
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameSincerus Florida, LLC
Substance NameLIDOCAINE HYDROCHLORIDE; FLUOCINOLONE ACETONIDE
Active Ingredient Strength1 g/100g; g/100g
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72934-1083-3

60 g in 1 BOTTLE, PUMP (72934-1083-3)
Marketing Start Date2019-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72934-1083-3 [72934108303]

FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1% GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

Drug Details

Active Ingredients

IngredientStrength
LIDOCAINE HYDROCHLORIDE1 g/100g

OpenFDA Data

SPL SET ID:8957cf62-ea51-3447-e053-2a95a90a536a
Manufacturer
UNII

Pharmacological Class

  • Amide Local Anesthetic [EPC]
  • Amides [CS]
  • Antiarrhythmic [EPC]
  • Local Anesthesia [PE]
  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]
  • Amide Local Anesthetic [EPC]
  • Amides [CS]
  • Antiarrhythmic [EPC]
  • Local Anesthesia [PE]
  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]

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