OXYMETAZOLINE HCL- oxymetazoline hcl spray 
Seaway Pharma Inc.

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

  • 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.

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 (1-800-222-1222) right away.

Directions

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

Inactive Ingredients

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

(pack: 30ml)  NDC# 73414-002-02

(pack: 15ml) NDC# 73414-002-13

Manufactured by:

Seaway Pharma Inc.

Massena, NY 13662

Carton30ml
carton15ml
OXYMETAZOLINE HCL 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73414-002
Route of AdministrationNASAL
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73414-002-021 in 1 CARTON01/01/2020
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:73414-002-171 in 1 CARTON01/01/2020
215 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2020
Labeler - Seaway Pharma Inc. (117218785)
Registrant - Seaway Pharma Inc. (117218785)
Establishment
NameAddressID/FEIBusiness Operations
Seaway Pharma Inc.117218785manufacture(73414-002)

Revised: 6/2020
Document Id: bc8cd053-70d3-45cf-8e1d-5b3edf833e5f
Set id: 29042ff4-82b1-428e-81d2-0f86d73caec3
Version: 2
Effective Time: 20200618
 
Seaway Pharma Inc.