Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 90125a19-eed7-4ca4-a6dc-f38026c74d54
Route
NASAL
Published
Effective Date 2026-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (.5 mg)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Eucalyptol Menthol, Unspecified Form Polyoxyl 40 Hydrogenated Castor Oil Water Sodium Chloride Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate, Monobasic, Unspecified Form Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Oxymetazoline HCl 0.05%

Uses
  • temporarily relieves nasal decongestion due to:
    • o
      common cold
    • o
      hay fever or other upper respiratory allergies (allergic rhinitis)
  • temporarily relieves stuffy nose
  • helps clear nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose
  • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
Directions
  • do not use more than directed
  • adults and children 6 years to under 12 years of age (with adult supervision): 2 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: consult a doctor

To Use: Shake well before use. To remove the cap, press grooves on each side and turn to lift cap. Before using the first time, prime the sprayer by pressing the button several times. To spray, insert sprayer tip into nostril, firmly press the button with thumb and sniff deeply. Stay upright while spraying. Wipe sprayer tip clean and secure cap after use.

Questions?

1-855-328-5259

Active Ingredient

Oxymetazoline HCl 0.05%

Other Information
  • do not store above 25°C (77°F)
Inactive Ingredients

benzalkonium chloride solution, edetate disodium, eucalyptol, menthol, polyoxyl 40 hydrogenated castor oil, purified water, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, sorbitol

Additional Information

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

Breathe Better at the Push of a Button

1. Find grooves on each side of cap

2. Press grooves and turn to lift cap

3. Press firmly with thumb

Do not use if red unlock icon is seen on either end of the carton before first opening or if the red unlock icon is absent after opening.

*vs. the leading nasal mist

When Using This Product
  • do not exceed recommended dosage
  • do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • the use of this container by more than one person may spread infection
Stop Use and Ask A Doctor If

symptoms persist

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control center right away.

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

NEW

THERAFLU

SEVERE

CONGESTION RELIEF

COOLING

NASAL MIST

Oxymetazoline HCl –

Nasal Decongestant

12 HR RELIEF

UNBLOCKS IN SECONDS

Comfortable to use

  • One-thumb push of a button
  • Shorter nozzle*
  • Ultra fine mist

0.34 FL OZ (10 mL)


Structured Label Content

Uses
  • temporarily relieves nasal decongestion due to:
    • o
      common cold
    • o
      hay fever or other upper respiratory allergies (allergic rhinitis)
  • temporarily relieves stuffy nose
  • helps clear nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose
  • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
Purpose

Nasal decongestant

Directions
  • do not use more than directed
  • adults and children 6 years to under 12 years of age (with adult supervision): 2 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: consult a doctor

To Use: Shake well before use. To remove the cap, press grooves on each side and turn to lift cap. Before using the first time, prime the sprayer by pressing the button several times. To spray, insert sprayer tip into nostril, firmly press the button with thumb and sniff deeply. Stay upright while spraying. Wipe sprayer tip clean and secure cap after use.

Questions?

1-855-328-5259

Active Ingredient (Active ingredient)

Oxymetazoline HCl 0.05%

Other Information (Other information)
  • do not store above 25°C (77°F)
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride solution, edetate disodium, eucalyptol, menthol, polyoxyl 40 hydrogenated castor oil, purified water, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, sorbitol

Additional Information

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

Breathe Better at the Push of a Button

1. Find grooves on each side of cap

2. Press grooves and turn to lift cap

3. Press firmly with thumb

Do not use if red unlock icon is seen on either end of the carton before first opening or if the red unlock icon is absent after opening.

*vs. the leading nasal mist

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • the use of this container by more than one person may spread infection
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms persist

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control center right away.

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
Package/label Principal Display Panel (Package/Label Principal Display Panel)

NEW

THERAFLU

SEVERE

CONGESTION RELIEF

COOLING

NASAL MIST

Oxymetazoline HCl –

Nasal Decongestant

12 HR RELIEF

UNBLOCKS IN SECONDS

Comfortable to use

  • One-thumb push of a button
  • Shorter nozzle*
  • Ultra fine mist

0.34 FL OZ (10 mL)


Advanced Ingredient Data


Raw Label Data

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