Oxymetazoline Hydrochloride Spray, Metered [Dynamic Pharmaceuticals] -

OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [DYNAMIC PHARMACEUTICALS]
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NDC	64762-864-15, 64762-864-22
Set ID	c82f6cb6-28dd-4a26-9456-225ec61e82d2
Category	HUMAN OTC DRUG LABEL
Packager	Dynamic Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number	PART341

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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

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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/04/2009

Labeler - Dynamic Pharmaceuticals (617660712)

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

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Medic

OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [DYNAMIC PHARMACEUTICALS]

Ask a doctor before use if you have

When using this product

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