SPL v3
SPL
SPL Set ID 35577fee-9d81-687f-e054-00144ff8d46c
Route
NASAL
Published
Effective Date 2016-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 mg)
Inactive Ingredients
Water Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Benzalkonium Chloride Edetate Disodium Polyethylene Glycols Propylene Glycol Povidone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Completed Since 2016-06-15 Until 2016-11-21

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses
  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • reduces swelling of nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor

To use Pump

  • shake well before use
  • to open the cap, hold the bottle with one hand, use the other hand to press groved area of cap firmly and turn counter closwise
  • line up the grooved line on the pump
  • to spray, hold with thumb at bottom of the bottle andnozzle between fingers. Before using the first time, prime pump by depressing pump firmly several times.
  • insert tip of nozzle into nostril. Pump 2 or 3 times into each nostril and sniff deeply without tilting head.
  • wipe nozzle clean after each use
  • to close the cap, turn unitl it 'clicks'
Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store between 20-25°C (68-77°F)
  • retain carton for future reference on full labelling
Inactive Ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water,

sodium phosphate dibasic, sodium phosphate monobasic

Questions Or Comments?

1-800-883-0085

When Using This Product
  • do not exceed recommended dosage
  • do not use for more than 3 days.
  • use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection
Principal Display Panel

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

Uses
  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • reduces swelling of nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nasal decongestant

Directions
  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor

To use Pump

  • shake well before use
  • to open the cap, hold the bottle with one hand, use the other hand to press groved area of cap firmly and turn counter closwise
  • line up the grooved line on the pump
  • to spray, hold with thumb at bottom of the bottle andnozzle between fingers. Before using the first time, prime pump by depressing pump firmly several times.
  • insert tip of nozzle into nostril. Pump 2 or 3 times into each nostril and sniff deeply without tilting head.
  • wipe nozzle clean after each use
  • to close the cap, turn unitl it 'clicks'
Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • retain carton for future reference on full labelling
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water,

sodium phosphate dibasic, sodium phosphate monobasic

Questions Or Comments? (Questions or comments?)

1-800-883-0085

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • do not use for more than 3 days.
  • use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection
Principal Display Panel (PRINCIPAL DISPLAY PANEL -)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)