NASAL DECONGESTANT- oxymetazoline hcl spray

Nasal Decongestant by

Drug Labeling and Warnings

Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Promex, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Oxymetazoline HCl 0.05%

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, 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.

Directions

• To spray, squeeze bottle qiuckly and firmly
• Do not tilt head backward while spraying
• Wipe nozzle clean after use
• 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 sprays in each nostril not more often than every 10 to 12 hours
• chlidren under 6 years of age: ask a doctor
  
  

Other information

• store at room temperature 15 - 30°C (59-86°F)
• retain carton for future reference on full labeling
• SAFETY SEAL: Do not use if seal on bottle is broken or missing

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Carton image

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT 
oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58988-0193
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58988-0193-5	1 in 1 BOX
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/09/2013

Labeler - Promex, LLC (789974388)