Oxymetazoline hydrochloride
Oxymetazoline Hydrochloride 0.05% Nasal Spray
3dce34f0-9f6d-8151-e063-6394a90a1d38
HUMAN OTC DRUG LABEL
Sep 2, 2025
Prodose, Inc.
DUNS: 119371190
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxymetazoline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
INDICATIONS & USAGE SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Oxymetazoline hydrochloride 0.05%
OTC - PURPOSE SECTION
Purpose
Nasal decongestant
WARNINGS SECTION
Warnings
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
OTC - WHEN USING SECTION
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
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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.
OTHER SAFETY INFORMATION
Other information
- store between 20° to 25°C (68° to 77°F)
- retain carton for future reference on full labelling
INACTIVE INGREDIENT SECTION
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