FDA Label for Breaze Nasal Moisturizing
View Indications, Usage & Precautions
Breaze Nasal Moisturizing Product Label
The following document was submitted to the FDA by the labeler of this product Samson Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Ask A Doctor Before Use If You Have
♦ High blood pressure♦ Heart disease♦ Diabetes♦ Thyroid diseases♦ Trouble urinating due to enlarged prostate gland
Otc - Do Not Use
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
Otc - Stop Use
Stop use and ask a doctor if symptoms persist
Otc - Pregnancy Or Breast Feeding
If pregnant or breast- feeding, ask a health professional before use.
Otc - 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
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, Edetate Disodium, Glycerin, Polyethelene Glycol, Povidone, Propylene Glycol, Sodium Diphospahte Dibasic, Sodium Phosphate Monobasic, Water.
Question Or Comments?
1-888-995-9935
Other
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
- Oxymetazoline HCl
Nasal Solution - Nasal Decongestant
1 FL OZ (30 mL)
* Please review the disclaimer below.
