12 HOUR NASAL- oxymetazoline hcl spray

12 Hour Nasal by

Drug Labeling and Warnings

12 Hour Nasal by is a Otc medication manufactured, distributed, or labeled by Healthlife of USA, Kingston Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Oxymetazoline HCL 0.05%

Purpose 

Nasal Decongestant 

Uses

Temporarily relieves nasal congestion due to:

• common cold
• hay fever
• upper respiratory allergies
• sinusitis 
• shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product: do not use more than directed

• do not use 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.

Directions

• 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. Do not exceed 2 doses in any 24-hour period.
• children under six years of age: ask a doctor.
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other Information

• store between 20°C to 40°C (68°F to 104°F)
• retain carton for future reference on full labeling.

Inactive Ingredients

benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, purified water.

Questions or Comments?

1-844-832-1138 Monday through Friday 9am-5pm

PRINCPAL DISPLAY PANEL - 15mL Bottle Carton

12 Hour Nasal Spray 

Nasal Decongestant 

Original 

0.5 Fl.OZ (15 mL)

INGREDIENTS AND APPEARANCE

12 HOUR NASAL 
oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-613
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)
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: 69517-613-17	1 in 1 CARTON	01/02/2018
1		15 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/02/2018

Labeler - Healthlife of USA (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Kingston Pharmaceuticals		080386521	manufacture(69517-613)