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  5. Label Information: Cleanoz

FDA Label for Cleanoz

View Indications, Usage & Precautions

Table of Contents

    1. USES
    2. WARNING
    3. OTC - WHEN USING
    4. DIRECTION
    5. INACTIVE INGREDIENT
    6. OTC - QUESTIONS
    7. PRINCIPAL DISPLAY PANEL

Cleanoz Product Label

The following document was submitted to the FDA by the labeler of this product Laboratoires Gifrer Barbezat. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.

Otc - 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.

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


Otc - Questions



Questions?   1-866-5-UBIMED   [email protected]


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

carton label picture - 09UBIMED CLEANOZ 20COUNT 08

carton label picture - 09UBIMED CLEANOZ 20COUNT 08


* Please review the disclaimer below.