ULTRA FINE MIST SINUS RELIEF- oxymetazoline hydrochloride spray

Ultra Fine Mist by

Drug Labeling and Warnings

Ultra Fine Mist by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP, 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 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

INGREDIENTS AND APPEARANCE

ULTRA FINE MIST  SINUS RELIEF
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-627
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)

Product Characteristics
Color	WHITE (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-627-30	1 in 1 CARTON	09/18/2020
1		30 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	09/18/2020

Labeler - DOLGENCORP, INC. (068331990)