Active Ingredient
Oxymetazoline HCl 0.05%
Nasal Decongestant Extra Moisturizing
FDA Label NDC 67510-0069
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Nasal Decongestant Extra Moisturizing (NDC 67510-0069). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal decongestant
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
Warnings
Do not use this product for more than 3 days
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
When Using This Product
- do not exceed recommended dosage
- use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen
- temporary discomfort such as burning, stinging, or an increase in nasal discharge may occur
- 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.
Directions
- Shake well before use.
- To spray, remove the clear plastic cap.
- Hold bottle with thumb at base and nozzle between first and second fingers. If this is the first time you are using the pump, spray several times into the air until you get a fine mist. If you have not used the pump for 14 days, spray several times into the air before using again.
- Insert nozzle into nostril. Spray upward while breathing in through the nose. Repeat in other nostril.
- Wipe nozzle clean after use. Put clear plastic cap back on the bottle
- Do not exceed 2 doses in any 24 hour period.
| adults and children 6 to under 12 years of age (with adult supervision) | 2 or 3 spray in each nostril not more often than every 10 to 12 hours |
| children under 6 years of age | ask a doctor |
Other Information
- store at room temperature(59°~86°F)
- retain carton for future reference on full labeling
Inactive Ingredients
benzalkonium chloride, concentrated glycerin, edetate disodium, purified water
Carton Image
Nasal Spray Extra Moisturizing
Carton (Nasalspray.ex.carton)
* Please review the disclaimer below.
