Label: BREAZE NASAL SINUS COLDS AND ALLERGIES- oxymetazoline hydrochloride 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.
Updated June 22, 2015
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Ask a doctor before use if you have
- High blood pressure
- Heart disease
- 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
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
- Question or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
INGREDIENTS AND APPEARANCE
BREAZE NASAL SINUS COLDS AND ALLERGIES
oxymetazoline hydrochloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20146-4006 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxymetazoline hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline hydrochloride 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:20146-4006-1 1 in 1 CARTON 1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 01/01/2015 Labeler - Samson Pharmaceuticals, Inc. (088169581) Establishment Name Address ID/FEI Business Operations Samson Pharmaceuticals, Inc. 088169581 MANUFACTURE(20146-4006)