Your browser does not support JavaScript! OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]
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OXYMETAZOLINE HCL (oxymetazoline hydrochloride) spray
[Perrigo New York Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

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

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • 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 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

  • 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. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other information

  • store at 20°-25°C (68°-77°F)
  • retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions?

1-800-719-9260

Principal Display Panel

Compare to Afrin® active ingredient

Oxymetazoline HCl 0.05%

Nasal Decongestant

Fast, Powerful Congestion Relief

12 Hour Relief

Spray Mist

Oxymetazoline HCl 0.05% Carton Image 1

Oxymetazoline HCl 0.05% Carton Image 1

Oxymetazoline HCl 0.05% Carton Image 2

Oxymetazoline HCl 0.05% Carton Image 2

OXYMETAZOLINE HCL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45802-410
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BENZYL ALCOHOL 
EDETATE DISODIUM 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
Product Characteristics
ColorWHITE (Translucent) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-410-591 in 1 CARTON
130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/05/2005
Labeler - Perrigo New York Inc (078846912)

Revised: 2/2012
 
Perrigo New York Inc

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