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 Select Brand Distributors, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Oxymetazoline HCl 0.05%

PURPOSE

Purpose
Oxymetazoline HCl................ Nasal decongestant

INDICATIONS & USAGE

Uses

• temporarily relieves nasal congestion due to:    common cold    hay fever    upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• shrinks swollen nasal membranes so you can breathe more freely

WARNINGS

​Warnings

Ask a doctor before use if you have

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

When using this product

• do not exceed recommended dosage
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
• do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• use only as directed
• 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.

DOSAGE & ADMINISTRATION

Directions

•  to spray, squeeze bottle quickly 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
• children under 6 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

•  RETAIN CARTON FOR FUTURE REFERENCE ON FULL LABELING
•  store between 2°-30°C (36°-86°F)

INACTIVE INGREDIENT

Inactive ingredients
benzalkonium chloride 0.01%, edetate disodium, polyethylene glycol 1450, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

PRINCIPAL DISPLAY PANEL

SelBr12hrNascart.jpg

INGREDIENTS AND APPEARANCE

12 HOUR NASAL 
oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-304
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 GLYCOL 1450 (UNII: OJ4Z5Z32L4)
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: 15127-304-10	1 in 1 CARTON	03/01/2000	04/30/2020
1		30 mL in 1 BOTTLE; 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	03/01/2000	04/30/2020

Labeler - Select Brand Distributors (012578514)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(15127-304) , pack(15127-304) , label(15127-304)