12 HOUR NASAL- oxymetazoline hcl spray
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Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient
Oxymetazoline HCl 0.05%

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

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

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.

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 information

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

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

carton

SelBr12hrNascart.jpg

12 HOUR NASAL
oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15127-304
Route of Administration	NASAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/01/2000	04/30/2020

Labeler - Select Brand Distributors (012578514)

Registrant - KC Pharmaceuticals, Inc. (174450460)

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

Revised: 10/2019

Document Id: 953bc381-626a-0446-e053-2995a90a2d5a

Set id: 62c62ba3-1f24-48f6-a5cd-106614646c2a

Version: 2

Effective Time: 20191018

Select Brand Distributors