Consumer medicine information

Flo Baby Nasal Spray

Sodium chloride; Sodium bicarbonate; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate

BRAND INFORMATION

Brand name

FLO Baby Saline +

Active ingredient

Sodium chloride; Sodium bicarbonate; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flo Baby Nasal Spray.

What you should know about your baby’s nose

The nasal passages in a baby’s nose are very small and easily blocked with excess mucus. Mucus is naturally produced in the nose and its role is to trap foreign particles such as dust, pollens and bacteria to help prevent them from entering the lungs. Mucus is also needed to protect the delicate nasal linings from drying out. The nose has a mucus transport system (this is made up of microscopic hairs called cilia) and it moves mucus from the front of the nose to the back of the throat from where it is then swallowed.

It is only when mucus is produced in excessive amounts that it becomes a problem. Most commonly, excess mucus is produced by the nasal lining in response to viral infections (colds) and allergy. Clearing your baby’s nose of excess mucus helps baby breathe more easily resulting in better feeding and sleeping.

What is FLO Baby Saline?

FLO Baby Saline is a sterile, preservative free, non-medicated, isotonic nasal saline spray. NOTE: For your convenience FLO Baby is also available in a metered drops pack. FLO Baby is a sterile and does not contain any chemical preservatives. The design of this device means no outside air or bacteria can contaminate the system.

FLO Baby Saline is isotonic which means it has the same concentration as the body’s own fluids. This helps to minimize any impact on the normal function of delicate nasal structures.

How does FLO Baby Saline help?

The gentle drops help to thin mucus and stimulate the natural cleansing action of the nose to clear it away. Sometimes your baby may sneeze – this is a natural cleansing action.

Dosage: Apply dose into each nostril as often as needed or as directed by your healthcare professional.

Newborn to 12 months – 1 spray

Over 12 months – 1 to 2 sprays

How do I use FLO Baby Saline?

FLO Baby Saline is presented in an advanced container and can be sprayed at any angle (even upside down). This enables you to place your baby in the most comfortable position making the administration of FLO Baby Saline quick and easy.

  1. Before using this product remove the protective cap and prime the pump by depressing your thumb several times until the first spray is seen. WARNING: Keep this product out of the reach of children.

The protective cap can become a choking hazard if children are able to play with it.
  1. Ensure your baby is comfortable and well supported

  1. Position FLO Baby Saline underneath the baby’s nostril and spray the required dose into each nostril. Caution: do not insert the tip of the spray into baby’s nose as sudden movement may cause injury.

  1. Wipe away any mucus from your baby’s nose using a clean tissue.
  2. When finished, clean the tip of the spray with a clean tissue and replace the protective cap. Ensure you store this medication out of the reach of children.

When does FLO Baby Saline expire?

FLO Baby Saline has an expiry date which can be found on the carton and bottle label. However, it must be discarded three months from the date of first use. For your convenience, space has been provided on the bottle label so you can record the discard date.

Can FLO Baby Saline be used if my baby is taking other medication?

FLO Baby Saline is non-medicated and can be used in conjunction with any other medication. If your baby is using other nasal medication, then you should allow 20 minutes between the administration of FLO Baby Saline and the other medication.

How often can I use FLO Baby Saline?

FLO Baby Saline can be used as often as needed. If baby’s nose is blocked or congested, then use it 5-10 minutes before feeding. Use at any time of the day or night if nasal congestion is causing baby to be unsettled.

Use this product only as directed and see your healthcare practitioner if symptoms persist.

For further information please contact:

ENT Technologies Pty Ltd
Suite 304, 12 Cato Street,
Hawthorn East, VIC 3123, Australia
Phone +61 3 9832 3700 or 1300 857 912
Fax +61 3 9832 3799

Email: info@enttech.com.au
Web: www.enttech.com.au
or visit the FLO Baby group on Facebook

This information leaflet was updated on 12th August 2015.

© ENT Technologies Pty Ltd 2009

Published by MIMS May 2020

BRAND INFORMATION

Brand name

FLO Baby Saline +

Active ingredient

Sodium chloride; Sodium bicarbonate; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate

Schedule

Unscheduled

 

Name of the medicine

Sodium chloride, anhydrous sodium bicarbonate, potassium chloride, calcium chloride and magnesium chloride hexahydrate and water. There are no preservatives and no other chemical additives.

Description

FLO Baby Saline + is a sterile, isotonic nasal spray with a pH of 7 to 8.5.

Indications

FLO Baby Saline + is used to reduce the thickness of nasal mucus and to cleanse the nose of pollens and other irritant particles. Thinning mucus will enable cilia to work more efficiently and effectively. The fine mist spray will also help to dislodge mucus and to physically move it towards the nasopharynx for swallowing.
The preparation can be used effectively in the following situations.
a. Congestion in infants (from upper respiratory tract infections). Infants always breathe through the nose and will persist in trying to do so even if it is congested (obligatory nasal breathers). This results in an unsettled child who will definitely experience difficulties when feeding or sleeping. Use of FLO Baby Saline + about 5 to 10 minutes prior to a feed will help to relieve the nasal congestion and will permit easy and successful feeding.
b. Hayfever. In children suffering from hayfever, flushing of the nasal cavity will help to reduce the pollen load. This will result in an improvement in symptoms. Clearing the nose of pollens and also of mucus which contains ‘cells and chemicals’ of the allergic reaction, will help to reduce the inflammatory response. It will also prepare the nasal epithelium for an application of nasal steroid. This may well result in improved penetration of the steroid spray with a subsequent reduction in nasal symptoms.
c. Postoperative. The postoperative use of FLO Baby Saline + will assist in washing out the mucus and blood clots that may impede healing in the nose.

Contraindications

There should be no contraindication to using this product.

Interactions

FLO Baby Saline + may be used while taking any other medication. There should be no interactions with any other medication. If it is being used in conjunction with other nasal sprays, then always allow at least 15 to 20 minutes between the use of FLO Baby Saline + and the administration of any medicated nasal spray.

Adverse Effects

There should be no stinging or pain when using this product.

Dosage and Administration

Dosage.

The frequency with which patients will require nasal treatment will vary as to the severity of symptoms and to the condition for which it is indicated. FLO Baby Saline + can be used as often as needed in all age groups, or as directed by healthcare practitioners.
Newborn infants to 12 months: 1 spray per nostril.
12 months and older: 2 sprays per nostril.
Each spray emits 0.14 mL of solution.
Do not share the container between patients as this may result in spread of infection.

Method of use.

FLO Baby Saline + is presented in a unique container and can be sprayed at any angle (even upside down). This enables baby to be placed in the most comfortable position and ensures that the administration process is quick, easy and less traumatic for both mother and baby.

First time use.

Remove the protective cap and then depress pump firmly several times until the first spray is seen.
Ensure baby is comfortable and well supported.
Position the nozzle underneath the baby's nostril and spray the required dose into each nostril. Caution should be observed to ensure that the nozzle is not inserted into the nostril, as sudden head movement could cause injury.

After use.

Wipe the nozzle with a clean tissue and replace the protective cap.
There is no need for suction of the nose after use as the mucus would have been pushed backwards towards the nasopharynx by the gentle mist spray. Simply wipe the baby's nose clean with a soft tissue.

Discard rules.

Since this product contains no preservatives, it can only be used for a period of three months after first use. There is provision to record a discard date on both the carton and label and this should be filled in at time of first use to ensure that the product is not used after that date.
Do not use the product if any of the outer packaging has been damaged in any way.

Presentation

Spray, 15 mL (bottle).

Storage

Shelf life.

FLO Baby Saline + has been marked with an expiry date indicated on the label and on the outer carton. It should not be used after the date shown.

Poison Schedule

Unscheduled.