Oxymetazoline Hydrochloride 0.05% Nasal Spray

Oxymetazoline Hydrochloride 0.05% Nasal Spray
SPL v4
SPL
SPL Set ID 3dce34f0-9f6d-8151-e063-6394a90a1d38
Route
NASAL
Published
Effective Date 2026-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Carboxymethylcellulose Sodium Water Cellulose, Microcrystalline Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Benzyl Alcohol Polyethylene Glycol, Unspecified Povidone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-03

Description

Active ingredient Oxymetazoline hydrochloride 0.05%


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

shrinks swollen nasal membranes so you can breathe more freely

Dosage and Administration

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.

Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.

Description

Active ingredient Oxymetazoline hydrochloride 0.05%

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 50567-7

When using this product

  • do not use more than directed
  • 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

Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Section 51727-6

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Nasal decongestant

Section 55106-9

Active ingredient

Oxymetazoline hydrochloride 0.05%

Section 60561-8

Other information

  • store between 20° to 25°C (68° to 77°F)
  • retain carton for future reference on full labelling


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

shrinks swollen nasal membranes so you can breathe more freely

Dosage and Administration (34068-7)

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.

Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.

Warnings and Precautions (34071-1)

Warnings

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 50567-7 (50567-7)

When using this product

  • do not use more than directed
  • 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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredient

Oxymetazoline hydrochloride 0.05%

Section 60561-8 (60561-8)

Other information

  • store between 20° to 25°C (68° to 77°F)
  • retain carton for future reference on full labelling


Advanced Ingredient Data


Raw Label Data

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