BREAZE NASAL  SINUS COLDS AND ALLERGIES- oxymetazoline hydrochloride spray 
Samson Pharmaceuticals, 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.

----------

Breaze® Nasal
Sinus Colds and Allergies

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

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

1 FL OZ (30 mL)

Principal Display Panel - 30 mL Bottle Carton
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)

Revised: 11/2022
Document Id: 0df89447-0374-443c-b1ec-ab0193380a4b
Set id: b1c948a9-dc6c-4cf4-88e0-105d564f6712
Version: 2
Effective Time: 20221129
 
Samson Pharmaceuticals, Inc.