Breaze
FDA Label NDC 20146-4000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Samson Pharmaceuticals, Inc. for the product Breaze (NDC 20146-4000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, ask a doctor before use if you have, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

    Principal Display Panel (30 mL Bottle Carton)

    Principal Display Panel (30 mL Bottle Carton)

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