NASAL DECONGESTANT EXTRA MOISTURIZING- oxymetazoline hcl spray

Nasal Decongestant Extra Moisturizing by

Drug Labeling and Warnings

Nasal Decongestant Extra Moisturizing by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. 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, 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

• Shake well before use.
• To spray, remove the clear plastic cap.
• Hold bottle with thumb at base and nozzle between first and second fingers. If this is the first time you are using the pump, spray several times into the air until you get a fine mist. If you have not used the pump for 14 days, spray several times into the air before using again.
• Insert nozzle into nostril. Spray upward while breathing in through the nose. Repeat in other nostril.
• Wipe nozzle clean after use. Put clear plastic cap back on the bottle
• 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 spray in each nostril not more often than every 10 to 12 hours
• children under 6 years of age: ask a doctor

Other information

• store at room temperature(59°~86°F)

• retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride, concentrated glycerin, edetate disodium, purified water

Carton image

Nasal Spray Extra Moisturizing

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT EXTRA MOISTURIZING 
oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0069
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)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0069-5	1 in 1 BOX	07/03/2013
1		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 67510-0069-1	1 in 1 BOX	07/03/2013
2		30 mL in 1 BOTTLE, PUMP; 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	08/12/2011

Labeler - Kareway Product, Inc. (121840057)