Fluocinonide Prescribing Information

Package insert / product label
Dosage form: cream
Drug class: Topical steroids

Medically reviewed by Drugs.com. Last updated on Nov 13, 2022.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1393-2

Fluocinonide Cream USP, 0.1%

Rx only

30 g

FLUOCINONIDE
fluocinonide cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FLUOCINONIDE (UNII: 2W4A77YPAN) (FLUOCINONIDE - UNII:2W4A77YPAN)	FLUOCINONIDE	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1393-2	30 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2020
2	NDC:70771-1393-3	60 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2020
3	NDC:70771-1393-5	120 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208989	04/30/2020

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		650650802	ANALYSIS(70771-1393) , MANUFACTURE(70771-1393)