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Fluocinonide

Dosage Form: cream

Medically reviewed by Drugs.com. Last updated on Aug 1, 2020.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1393-2

Fluocinonide Cream USP, 0.1%

Rx only

30 g

Fluocinonide
Fluocinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1393
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
ANHYDROUS CITRIC ACID
CARBOMER HOMOPOLYMER TYPE C
DIETHYLENE GLYCOL MONOETHYL ETHER
DIISOPROPANOLAMINE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
PROPYLENE GLYCOL
WATER
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:70771-1393-2 30 g in 1 TUBE
2 NDC:70771-1393-3 60 g in 1 TUBE
3 NDC:70771-1393-5 120 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208989 04/30/2020
Labeler - Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 650650802 ANALYSIS(70771-1393), MANUFACTURE(70771-1393)
Cadila Healthcare Limited

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