Label: BREAZE NASAL SINUS COLDS AND ALLERGIES- oxymetazoline hydrochloride spray

  • NDC Code(s): 20146-4006-1
  • Packager: Samson Pharmaceuticals, Inc.
  • 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 November 29, 2022

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  • SPL UNCLASSIFIED SECTION

    DRUG FACT

  • ACTIVE INGREDIENT

    Oxymetazoline hydrochloride, 0.05%

  • PURPOSE

    Nasal Decongestant

  • Uses

    ♦
    Temporarily relieves nasal congestion due to:
    ♦
    Common cold. Hay fever. Sinusitis
    ♦
    Upper respiratory allergies
    ♦
    Shrinks swollen nasal membranes so you can breathe more freely
  • Warnings

    Ask a doctor before use if you have

    ♦
    High blood pressure
    ♦
    Heart disease
    ♦
    Diabetes
    ♦
    Thyroid diseases
    ♦
    Trouble urinating due to 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

    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

    ♦
    Store between 20C to 25C (68 to 77F).
    ♦
    Retain carton for future reference on full labeling.
  • Inactive Ingredients

    Benzalkonium Chloride, Eucalyptus Globulus (Eucaplyptus) Leaf Oil, Camphor, Menthol, Editate Disodium, Sodium Phosphate Dibasic, Polysorbate 80, Sodium Phosphate Monobasic, Propylene Glycol, Water (Aqua).

  • 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

    Breaze®

    MADE IN THE U.S.A.
    WITH PRIDE

    Relieves Congestion

    Nasal
    Spray

    Sinus
    Colds & Allergies

    12 Hour Relief

    • Oxymetazoline HCl
      Nasal Solution
    • Nasal Decongestant

    1 FL OZ (30 mL)

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BREAZE NASAL   SINUS COLDS AND ALLERGIES
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20146-4006
    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)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Sodium Phosphate, Monobasic, Anhydrous (UNII: KH7I04HPUU)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20146-4006-11 in 1 CARTON01/01/2015
    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(20146-4006)
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