Active Ingredient
Oxymetazoline hydrochloride 0.05%
Ultra Fine Mist Spray
FDA Label NDC 55910-627
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. for the product Ultra Fine Mist (NDC 55910-627). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., 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 a cold, heavy fever, or other upper respiratory allergies▪ sinus congestion and pressure
Ask A Doctor Before Use If You Have
▪ heart disease▪ high blood pressure▪ diabetes▪ thyroid disease▪ trouble urinating due to an enlarged prostate gland
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.▪ 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
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 at (1-800-222-1222).
Directions
▪ adults & children 6 to under 12 years of age & older (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 2 to under 6 years: ask a doctor▪ children 2 years: do not use
To Use: Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim.Before using the first time, 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 titling head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.
Other Information
▪ store at room temperature
Inactive Ingredients
benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC# 55910-627-30
Compare to the active ingredient in Vicks® Sinex™ Severe Original*
ULTRA FINE MIST
SINUS RELIEF
Oxymetazoline HCl
Nasal Decongestant
Original
- Fast Sinus Congestion & Pressure Relief
12 Hour
Pump Mist
1 FL OZ (30 mL)
IMPORTANT: Keep the carton for future reference on full labeling |
Distributed by:
*This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks® Sinex™ Severe Original
* Please review the disclaimer below.
