OXYMETAZOLINE HYDROCHLORIDE- oxymetazoline hydrochloride spray 
CHAIN DRUG MARKETING ASSOCIATION 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 Decongestant

Active Ingredient                         Purpose

Oxymetazoline HCl 0.05%............. Nasal decongestant

Nasal Decongestant

Uses

Warnings

Ask a doctor before use if you have

  • heart disease 
  • thyroid disease
  • high blood pressure
  • 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 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

Other information

Inactive ingredients

Questions or comments?1-800-935-2362, Mon-Fri. 9 am-5 pm EST)

Distributed by C.D.M.A Inc.
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Question: 800-935-2362

PRINCIPAL DISPLAY PANEL

NDC-63868-605-01

containerlabel605

NDC-63868-676-01

containerlabel676

OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-605
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-605-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/2021
OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-676
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
glycerin (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-676-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/2021
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774)
Registrant - Seaway Pharma Inc. (117218785)
Establishment
NameAddressID/FEIBusiness Operations
Seaway Pharma Inc.117218785manufacture(63868-605, 63868-676)

Revised: 8/2021
Document Id: 7abfe9c8-a55e-4b62-84a3-fa5f14aae007
Set id: c7b1f980-9b0d-4f63-a70d-fd366658f863
Version: 1
Effective Time: 20210803
 
CHAIN DRUG MARKETING ASSOCIATION INC.