FLUOCINONIDE

FLUOCINONIDE- fluocinonide cream
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1393-2

Fluocinonide Cream USP, 0.1%

Rx only

30 g

Fluocinonide Cream
(click image for full-size original)
Fluocinonide Cream
(click image for full-size original)
FLUOCINONIDE
fluocinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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 Multilevel Packaging
1 NDC:70771-1393-2 30 g in 1 TUBE None
2 NDC:70771-1393-3 60 g in 1 TUBE None
3 NDC:70771-1393-5 120 g in 1 TUBE None
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)

Revised: 08/2020 Cadila Healthcare Limited

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