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OXYMETAZOLINE HCl by PURINEPHARMA LLC

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.5mg in 1mL
Labeler: PURINEPHARMA LLC
NDC Code: 58599-027

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.

NASAL SPRAY - ORIGINAL 15mL and 30mL

Active Ingredient: Oxymetazoline HCl 0.05%

Purpose: Nasal Decongestant

Uses
Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • shrinks swollen nasal membrances so you can breathe more freely.

Ask a doctor before use if you have

  • 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.

When using this product

  • Frequent or prolonged use may cause nasal congestion to rcur or worsen
  • temporary discomfort such as buming, 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 nostrill not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
Children under six 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.

Store between 20°C to 25°C (68° to 77° F)

Retain carton for future reference on full labeling.

Purified Water, Edetate Disodium, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Povidone, Benzalkonium Chloride Solution, Polyethylene Glycol, Propylene Glycol

NDC 58599-027-01: 30 mL in a Bottle, NDC 58599-027-17: 15 mL in a Bottle

OXYMETAZOLINE HCL 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-027
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
EDETATE DISODIUM 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
POVIDONE K90 
BENZALKONIUM CHLORIDE 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:58599-027-011 BOTTLE (1 BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
2NDC:58599-027-171 BOTTLE (1 BOTTLE) in 1 CARTON
215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/09/2015
Labeler - PURINEPHARMA LLC (019950491)
Registrant - PURINEPHARMA LLC (019950491)
Establishment
NameAddressID/FEIOperations
PURINEPHARMA LLC019950491manufacture(58599-027)

 
PURINEPHARMA LLC

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Medically reviewed on Feb 13, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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