Xylometazoline Hydrochloride Nasal Drops 0.1%w/v Technical Specification:

Product Name:Xylometazoline Hydrochloride Nasal Drops
Brand Name:Notrin

Strength: 
Pediatrics: 0.05%w/v,
Adult: 0.1%w/v
Dosage Form:Nasal Drops
Route of Administration:For intra nasal use only
Packing:10ml Bottle
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Decongestants, Vasoconstriction
Indication: Xylometazoline Nasal Drops is used to treat stuffy nose caused by allergies, sinus irritation, or the common cold.
Storage:Store in cool, dry place, away from direct heat and light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Xylometazoline Hydrochloride Nasal Drops 0.1%w/v (Notrin) (Adult)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Xylometazoline Hydrochloride Nasal Drops 0.1%w/v (Adult)
    Composition:
    Xylometazoline Hydrochloride USP………………………0.1%w/v
    Benzalkonium Chloride Solution USP…………………….0.02%v/v
    (As preservative)
    An Aqueous Isotonic Base………………………………………q.s.

THERAPEUTIC INDICATIONS:

Xylometazoline Nasal Drops is used for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies.

DIRECTION OF USE:

  1. Clear the nose by blowing gently.
  2. Lie with head lower than shoulders.
  3. Insert droppers pipette a little way into each nostril & apply 2-3 drops.
  4. Remain still for few minutes.

CAUTION & WARNING:

CAUTION:  

FOR NASAL USE ONLY.
SHAKE WELL BEFORE USE
Keep medicine out of reach of children
Read enclosed leaflet before use.

WARNING: 1. Do not touch the Nozzle tip as this may contaminate the solution.
2. Use the solution within one month. after opening the container.

STORAGE & DOSAGE:

Storage: Store in cool, dry place, away from direct heat and light.
To avoid contamination, do not keep part-used bottles of nose drops or nasal sprays to use later.
Throw away the container after each course of treatment.

Dosage:  Children Over 2years: 2-3 drops into each nostril per application, A total of 3-4 applications per day is usually sufficient.

Adults and children over 6 years: 2-3 drops into each nostril per application, A total of 3-4 applications per day is usually sufficient.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Xylometazoline Hydrochloride Nasal Drops 0.05%w/v (Notrin) (Pediatric)
B. Xylometazoline Hydrochloride Nasal Drops 0.1%w/v (Notrin) (Adult)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Xylometazoline Hydrochloride Nasal Drops 0.05%w/v (Notrin)
Composition:
Xylometazoline Hydrochloride USP……………………...0.05%w/v
Benzalkonium Chloride Solution USP…………………….0.02%v/v
(As preservative)
An Aqueous Isotonic Base………………………………………q.s.

B. Xylometazoline Hydrochloride Nasal Drops 0.1%w/v (Notrin)
Composition:
Xylometazoline Hydrochloride USP……………………...0.1%w/v
Benzalkonium Chloride Solution USP…………………….0.02%v/v
(As preservative)
An Aqueous Isotonic Base………………………………………q.s.


THERAPEUTIC INDICATIONS:

Xylometazoline Nasal Drops is used for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies.

DIRECTION OF USE:

1. Clear the nose by blowing gently.
2. Lie with head lower than shoulders.
3. Insert droppers pipette a little way into each nostril & apply 2-3 drops.
4. Remain still for few minutes.

CAUTION & WARNING:

CAUTION:
FOR NASAL USE ONLY.
SHAKE WELL BEFORE USE
KEEP MEDICINE OUT OF REACH OF CHILDREN
Read enclosed leaflet before use.
WARNING: 1. Do not touch the Nozzle tip as this may contaminate the solution. 2. Use the solution within one month. after opening the container.

STORAGE & DOSAGE:

Storage: Store in cool, dry place, away from direct heat and light.
To avoid contamination, do not keep part-used bottles of nose drops or nasal sprays to use later.
Throw away the container after each course of treatment.
Dosage: Children Over 2years: 2-3 drops into each nostril per application, A total of 3-4 applications per day is usually sufficient.
Adults and children over 6 years: 2-3 drops into each nostril per application, A total of 3-4 applications per day is usually sufficient.