Fluocinonide (Page 4 of 4)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 30 g Carton

Rx Only

Fluocinonide Cream USP, 0.1%

For Topical Use Only. Not for Ophthalmic, Oral, or Intravaginal Use.

NET WT 30 g

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The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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FLUOCINONIDE
fluocinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-151
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fluocinonide (Fluocinonide) Fluocinonide 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
CITRIC ACID MONOHYDRATE
DIISOPROPANOLAMINE
GLYCERIN
GLYCERYL MONOSTEARATE
GLYCERYL 1-STEARATE
ISOSTEARIC ACID
PEG-100 STEARATE
PROPYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-151-94 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (45802-151-94)
2 NDC:45802-151-96 1 TUBE in 1 CARTON contains a TUBE
2 60 g in 1 TUBE This package is contained within the CARTON (45802-151-96)
3 NDC:45802-151-53 1 TUBE in 1 CARTON contains a TUBE
3 120 g in 1 TUBE This package is contained within the CARTON (45802-151-53)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090256 01/14/2014
Labeler — Perrigo New York Inc (078846912)

Revised: 02/2020 Perrigo New York Inc

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