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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 Cream
Fluocinonide Cream
FLUOCINONIDE
fluocinonide cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1393
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUOCINONIDE (UNII: 2W4A77YPAN) (FLUOCINONIDE - UNII:2W4A77YPAN) FLUOCINONIDE1 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
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)
Product Characteristics
ColorWHITE (white to off-white) Score
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1393-230 g in 1 TUBE; Type 0: Not a Combination Product04/30/2020
2NDC:70771-1393-360 g in 1 TUBE; Type 0: Not a Combination Product04/30/2020
3NDC:70771-1393-5120 g in 1 TUBE; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20898904/30/2020
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1393) , MANUFACTURE(70771-1393)

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