FDA Label for Cvs Health Ultra Fine Mist
View Indications, Usage & Precautions
Cvs Health Ultra Fine Mist Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Oxymetazoline hydrochloride 0.05%
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 years & 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: ask a doctor
Shake well before use. Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap. Rotate the lock tab to align arrow marks to unlock the pump. 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. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip.
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
CVS Health™
NDC# 69842-726-16
Compare to the active ingredient in Vicks® Sinex™ Severe Original*
Ultra Fine Mist
12 HOUR
Sinus Relief
OXYMETAZOLINE HCl 0.05%
Nasal decongestant
FOR SINUS RELIEF
• Fast acting day/night relief• Moisturizing• Cold & allergy congestion• Sinus pressure• Ultra fine pump mist✓ CVS QualityMoney Back Guarantee
Package contains One Bottle B
Actual Bottle Size on Side Panel
0.5 FL OZ (15 mL)
IMPORTANT: KEEP THE CARTON FOR FUTURE REFERENCE ON FULL LABELING |
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
2019 CVS/pharmacy
CVS.com
1-800-SHOP CVS, V-12431
*This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks® Sinex™ Severe Original.
* Please review the disclaimer below.