CVS HEALTH ULTRA FINE MIST- oxymetazoline hydrochloride spray

CVS Health by

Drug Labeling and Warnings

CVS Health by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Warnings

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™

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

Actual Bottle Size on Side Panel

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

• ✓ CVS Quality

  Money Back Guarantee

  Package contains One Bottle B

*This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks® Sinex™ Severe Original.

PACKAGE LABEL 15 mL

Package Label Twin Pack 30 mL

INGREDIENTS AND APPEARANCE

CVS HEALTH  ULTRA FINE MIST
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-726
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-726-16	1 in 1 CARTON	03/12/2019
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 69842-726-30	2 in 1 CARTON	03/12/2019
2		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/12/2019

Labeler - CVS PHARMACY, INC. (062312574)