OXYMETAZOLINE HYDROCHLORIDE spray, metered

Oxymetazoline Hydrochloride by

Drug Labeling and Warnings

Oxymetazoline Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Dynamic Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

Temporarily relieves nasal congestion due to:

• common cold
• hay fever
• upper respiratory allergies
• helps clear nasal passages
• shrinks swollen membranes
• temporarily relieves sinus congestion and pressure

Warnings

For nasal use only.

Ask a doctor before use if you have

• heart disease
• 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 result
• 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 6-12 years of age (with adult supervision): Pump 2 or 3 times in each nostril without tilting your head. Sniff deeply. Wipe nozzle clean after use.
• Do not use more often than once every 10 to 12 hours.
• Do not exceed 2 doses in any 24 hour period.
• Children under 6 years of age: consult a doctor

To use pump:

• Remove cap and safety clip.
• Hold with thumb at bottom of bottle and nozzle between fingers.
• Before using the first time, prime pump by depressing several times.

Other Information

• Retain carton for future reference on full labeling
• Remove lock ring before each use

Inactive Ingredients

aloe barbadensis gel, d-alpha-tocopherol-ester, disodium EDTA, disodium phosphate, ethylene & propylene oxide copolymer, eucalyptol, hydroxyethylcellulose, hydroxylated lecithin, menthol, monosodium phosphate, potassium sorbate, purified water

SPL UNCLASSIFIED SECTION

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 15 mL Carton

CVS®
pharmacy

Compare to the active
ingredient in Zicam®*

NEW!

Maximum
SINUS RELIEF
NO DRIP NASAL GEL
OXYMETAZOLINE HCl 0.05%

Quickly relieves sinus
pressure & nasal congestion

• Long-lasting
• Non-drowsy

12
Hour
Relief

Menthol Eucalyptus

0.5 FL OZ (15mL)

INGREDIENTS AND APPEARANCE

OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64762-864
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY)	Oxymetazoline Hydrochloride	0.2 mg  in 0.4 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64762-864-15	1 in 1 CARTON
1		15 mL in 1 BOTTLE, PUMP
2	NDC: 64762-864-22	1 in 1 CARTON
2		22 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/04/2009

Labeler - Dynamic Pharmaceuticals (617660712)

Establishment
Name	Address	ID/FEI	Business Operations
Dynamic Pharmaceuticals		617660712	MANUFACTURE