OXYMETAZOLINE HCL- oxymetazoline hcl spray 
PURINEPHARMA LLC

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.

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NASAL SPRAY - ORIGINAL 15mL and 30mL

Active Ingredient: Oxymetazoline HCl 0.05%

Purpose: Nasal Decongestant

Uses
Temporarily relieves nasal congestion due to:

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

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

Nasal Spray
Label Text
Carton
OXYMETAZOLINE HCL 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-027
Route of AdministrationORAL, Type 0: Not a Combination Product
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58599-027-011 in 1 CARTON
130 mL in 1 BOTTLE
2NDC:58599-027-171 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/FEIBusiness Operations
PURINEPHARMA LLC019950491manufacture(58599-027)

Revised: 2/2015
Document Id: 4dddfee7-1b3d-4b5f-9051-13aa25385922
Set id: bde446d1-f867-41c1-9bfa-79bb8ff65f24
Version: 2
Effective Time: 20150213
 
PURINEPHARMA LLC