Cleanoz
FDA Label NDC 44929-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Gifrer Barbezat for the product Cleanoz (NDC 44929-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding uses, warning, otc - when using, direction, inactive ingredient, otc - questions, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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)

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