Prescription Drug Information: Zetonna (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — Carton Label

Principal Display Panel -- Carton Label
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Carton Label

NDC 70515-737-60

Net Contents: 6.1 g

Zetonna™
(ciclesonide) Nasal Aerosol

37 mcg per actuation

For Intranasal Use Only.
Zetonna™ Nasal Aerosol Canister
Should Be Used with Zetonna™
Nasal Aerosol Actuator Only.

60 Metered Actuations

Rx Only

COVIS

Each 6.1 g canister of Zetonna™
Nasal Aerosol contains a solution of
ciclesonide in propellant HFA-134a
(1,1,1,2 tetrafluoroethane) and
ethanol. The 37 mcg strength of
Zetonna™ Nasal Aerosol delivers
37 mcg of ciclesonide from the
actuator.

Usual Dosage:
See Prescribing Information.

Avoid spraying in eyes.

CONTENTS UNDER PRESSURE.
Do not puncture. Do not use or store
near heat or open flame. Exposure
to temperatures above 49°C (120°F)
may cause bursting. Never throw
canister into fire or incinerator.

Store at 25°C (77°F); excursions
between 15°–30°C (59°–86°F)
are permitted [see USP]. For optimal
results, canister should be at room
temperature when used.

Pharmacist: Dispense with Patient’s
Instructions for Use from package
insert.

Keep out of reach of children.

Manufactured for
Covis Pharma
Zug, 6300 Switzerland

Made in the United Kingdom

© 2018 Covis Pharma and AstraZeneca
group of companies. All rights reserved.

Zetonna™
(ciclesonide) Nasal Aerosol

37 mcg per actuation

60 Metered Actuations

GTIN: XXXXXXXXXXXXXX
SN: XXXXXXXXXXXXXX
EXP: MM-YYYYLOT: XXXXXXX

ZETONNA ciclesonide aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-737
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CICLESONIDE (CICLESONIDE) CICLESONIDE 37 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-737-60 1 CANISTER in 1 CARTON contains a CANISTER
1 60 AEROSOL, METERED in 1 CANISTER This package is contained within the CARTON (70515-737-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202129 04/30/2018
Labeler — Covis Pharma (486209070)

Revised: 11/2019 Covis Pharma

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