Label: OXYMETAZOLINE HCL spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 June 18, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient: Oxymetazoline HCl 0.05%

  • PURPOSE

    Purpose: Nasal Decongestant

  • INDICATIONS & USAGE

    Uses
    Temporarily relieves nasal congestion due to:

    • common cold
    • hay fever
    • upper respiratory allergies
    • shrinks swollen nasal membrances so you can breathe more freely.
  • WARNINGS

    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.
  • WHEN USING

    • 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
  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    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 6 years of age: consult a doctor.

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

  • STORAGE AND HANDLING

    • store between 20°C to 25°C (68° to 77° F)
    • retain carton for future reference on full labeling
  • INACTIVE INGREDIENT

    Inactive Ingredients

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

  • HOW SUPPLIED

    (pack: 30ml)  NDC# 73414-002-02

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

    Manufactured by:

    Seaway Pharma Inc.

    Massena, NY 13662

  • PRINCIPAL DISPLAY PANEL

    Carton30ml
    carton15ml
  • INGREDIENTS AND APPEARANCE
    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)
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