Oxymetazoline Hydrochloride

Oxymetazoline Hydrochloride
SPL v3
SPL
SPL Set ID 34a79f8b-32b7-48db-a895-c942cc795292
Route
NASAL
Published
Effective Date 2019-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Anhydrous Edetate Disodium Sodium Phosphate, Monobasic, Monohydrate Polyethylene Glycol 1450 Povidone, Unspecified Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-02-25
Description

Drug Facts

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses
  • temporary relief of nasal congestion
    • due to the common cold
    • due to hay fever or other upper respiratory allergies
    • associated with sinusitis
  • reduces swelling of nasal passages
  • 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 53414-9

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

Warnings

Do not exceed recommended dosage

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

Directions
  • Adults and children 6 to under 12 years of age (with supervision): 2 to 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 spray: squeeze the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Do Not Use
  • for more than 3 days
Questions?

Call 1-866-923-4914

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Inactive Ingredients

benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), polyethylene glycol 1450, povidone, propylene glycol, purified water.

When Using This Product
  • frequent or prolonged use may cause nasal congestion to recur or worsen
Stop Use and Ask A Doctor If
  • symptoms persist
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Principal Display Panel 30 Ml Bottle Carton

Compare to the

active ingredient

in Afrin ®*

Nasal

Decongestant

12- Hour Spray

Oxymetazoline

Hydrochloride 0.05%

Maximum Strength

  • Fast Acting
  • Up To 12 Hours Relief

Contains the Active Ingredient

Recommended Most by

Physicians and Pharmacists

12

1 fl oz (30 mL)

Structured Label Content

Uses
  • temporary relief of nasal congestion
    • due to the common cold
    • due to hay fever or other upper respiratory allergies
    • associated with sinusitis
  • reduces swelling of nasal passages
  • 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 53414-9 (53414-9)

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

Purpose

Nasal decongestant

Warnings

Do not exceed recommended dosage

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

Directions
  • Adults and children 6 to under 12 years of age (with supervision): 2 to 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 spray: squeeze the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Do Not Use (Do not use)
  • for more than 3 days
Questions?

Call 1-866-923-4914

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), polyethylene glycol 1450, povidone, propylene glycol, purified water.

When Using This Product (When using this product)
  • frequent or prolonged use may cause nasal congestion to recur or worsen
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms persist
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Principal Display Panel 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)

Compare to the

active ingredient

in Afrin ®*

Nasal

Decongestant

12- Hour Spray

Oxymetazoline

Hydrochloride 0.05%

Maximum Strength

  • Fast Acting
  • Up To 12 Hours Relief

Contains the Active Ingredient

Recommended Most by

Physicians and Pharmacists

12

1 fl oz (30 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:43.762474 · Updated: 2026-03-14T23:07:58.892866