CLEANOZ- sodium chloride solution

Cleanoz by

Drug Labeling and Warnings

Cleanoz by is a Otc medication manufactured, distributed, or labeled by Laboratoires Gifrer Barbezat. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

• Recommended for nasal rinsing in babies, children and adults.

Recommended for the following cases:

• Hygiene of nasal passage: Pollution, dry air, airconditioning, dust, pollen.
• Moisture efficiency.
• Nasal drainage. For babies and infants, this can be assisted with the use of Cleanoz® nasal aspirator kitTM

Warning

For external use only, do not inject

• Do not use if solution changes color or becomes cloudy.

WHEN USING

When using this product

• Use only if applicator is intact.
• To avoid contamination, do not touch tip of the container to any surface.
• Do not reuse. Once opened, discard.
• Do not use the same applicator on different people.

Keep out of reach of children.

Direction

• Twist and pull tab to remove.
• Tilt on the applicator to obtain the necessary dosage.
• Directions for use for babies and infants: Place the baby with its head leaning to the side. Place carefully the tip of the applicator in one nostril. Tilt to obtain the necessary dosage. Repeat on the other nostril.
• Use as often as needed for any length of time or as directed by physician. Non habit forming.

Other information

• Store at 68-77°F (20-25°C).
• Retain this carton for future reference.
• Use before expiration date marked on the carton or containers.

INACTIVE INGREDIENT

Inactive ingredients

Purified water, 0.9% Sodium Chloride

QUESTIONS

Questions?   1-866-5-UBIMED   info@ubimed.com

Principal Display Panel

Cleanoz(R)

Saline solution

Natural relief for dry or stuffy noses

Convenient and hygienic

Newborns to adults

The #1 Choice of Healthcare Professionals

Preservative-free vials

Ubimed

3/5/10/20/30/40 Count

3/5/10/20/30/40 Sterile Single-Use Applicators

5mL (0.169 FL OZ) Each

INGREDIENTS AND APPEARANCE

CLEANOZ  
sodium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44929-002
Route of Administration	NASAL, OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
sodium chloride (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37)	sodium chloride	900 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44929-002-02	20 in 1 CARTON
1	NDC: 44929-002-01	5 mL in 1 AMPULE
2	NDC: 44929-002-03	3 in 1 CARTON
2	NDC: 44929-002-01	5 mL in 1 AMPULE
3	NDC: 44929-002-04	5 in 1 CARTON
3	NDC: 44929-002-01	5 mL in 1 AMPULE
4	NDC: 44929-002-05	40 in 1 CARTON
4	NDC: 44929-002-01	5 mL in 1 AMPULE
5	NDC: 44929-002-06	10 in 1 CARTON
5	NDC: 44929-002-01	5 mL in 1 AMPULE
6	NDC: 44929-002-07	30 in 1 CARTON
6	NDC: 44929-002-01	5 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part341	11/25/2008

Labeler - Laboratoires Gifrer Barbezat (278133806)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Gifrer Barbezat		278133806	manufacture