Label: OXYMETAZOLINE HYDROCHLORIDE spray

  • NDC Code(s): 63868-605-01, 63868-676-01
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC.
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated August 3, 2021

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  • Active Ingredient                         Purpose

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

  • PURPOSE

    Nasal Decongestant

  • Uses

    • temporarily relieves nasal congestion due to:
      • common cold
      • hay fever
      • upper respiratory allergies
    • shrinks swollen nasal membranes so you can breathe more freely
  • 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

    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

    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 nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period.
    • children under 6 years of age: ask a doctor
    • Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides and tum in a counter-clockwise direction and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tiltlng the head insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap back onto the bottle.
  • Other information

    • store between 20˚C to 25˚C (68˚F to 77˚F)
    • retain carton for future reference on full labeling
  • Inactive ingredients

    • No Drip Original Nasal Pump Mist- (NDC-63868-605-01) avicel. benzalkonium chloride, benzyl alcohol. dibasic sodium phosphate, edetate disodium dihydrate, flavor, monobasic sodium phosphate, polyethylene glycol, povidone, purified water
    • No Drip Extra Moisturizing Nasal Pump Mist- (NDC-63868-676-01) avicel. benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium dihydrate, glycerin, monobasic sodium phosphate, polyethylene glycol, povidone, purified water
  • SPL UNCLASSIFIED SECTION

    • Tamper Evident: Do not use the product if the temper evident seal is broken or missing.
    • This product is not manufactured or distributed by Bayer HealthCare LLC distributor of Afrin Original Nasal Spray.

    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

  • INGREDIENTS AND APPEARANCE
    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)
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