OXYMETAZOLINE HYDROCHLORIDE- oxymetazoline hydrochloride solution 
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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No Drip Severe Congestion

Nasal Pump Mist

Active Ingredient                         Purpose

Oxymetazoline HCI 0.05% ....... Nasal decongestant

Uses

Warnings

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

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

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

Inactive ingredients

avicel, benzalkonium chloride, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium dihydrate, eucalyptol, menthol, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

*This product is not manufactured or distributed by Bayer HealthCare LLC mdistributor of Afrin No Drip Severe Congestion

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

PRINCIPAL DISPLAY PANEL

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OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-608
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EUCALYPTOL (UNII: RV6J6604TK)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-608-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/15/2021
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Registrant - Seaway Pharma Inc. (117218785)
Establishment
NameAddressID/FEIBusiness Operations
Seaway Pharma Inc.117218785manufacture(63868-608)

Revised: 8/2021
Document Id: 3421a196-7c1a-41a6-8e10-8532c58629ef
Set id: aebc7cf8-aaf7-4746-89f5-a64d0be1641e
Version: 1
Effective Time: 20210801
 
CHAIN DRUG MARKETING ASSOCIATION INC