BREAZE NASAL MOISTURIZING- oxymetazoline hydrochloride spray

Breaze by

Drug Labeling and Warnings

Breaze by is a Otc medication manufactured, distributed, or labeled by Samson Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

    Adult & children 6 to under 12 years of age (with adult supervision): 2 to 3 sprays in age nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 –hr period.

    Children under 6 years of age: ask a doctor. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

  • Other information

  • Inactive Ingredients

    Benzalkonium Chloride, Edetate Disodium, Glycerin, Polyethelene Glycol, Povidone, Propylene Glycol, Sodium Diphospahte Dibasic, Sodium Phosphate Monobasic, Water.

  • Question or Comments?

    1-888-995-9935

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Samson Pharmaceutical
    Commerce, CA 90040
    Made in USA

    Visit our website at
    www.samson.pharmaceutical.com
    Made in USA

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    MADE IN THE U.S.A.
    WITH PRIDE

    Breaze®

    Relieves Congestion

    Nasal
    Spray

    Moisturizing

    12 Hour Relief

    1 FL OZ (30 mL)

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BREAZE   NASAL MOISTURIZING
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 20146-4000
    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)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
    Povidones (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Sodium Phosphate, Monobasic, Anhydrous (UNII: KH7I04HPUU)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 20146-4000-21 in 1 CARTON
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/01/2015
    Labeler - Samson Pharmaceuticals, Inc. (088169581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Samson Pharmaceuticals, Inc.088169581MANUFACTURE(20146-4000)

  • Trademark Results [Breaze]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BREAZE
    BREAZE
    78346200 not registered Dead/Abandoned
    NuLiv Science USA, Inc.
    2003-12-29

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