Breaze ® Nasal Spray Moisturizing

Manufacturer: Samson Pharmaceuticals, Inc.
Effective date: 2022-11-29
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:55:39

Label at a glance#

ProductBreaze Nasal Moisturizing

Active ingredientOxymetazoline hydrochloride

Label structure11 sections

Indications and 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

Dosage and administration

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.

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-888-995-9935

Websitewww.samson.pharmaceutical.com

www.samson.pharmaceutical.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACT

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline hydrochloride, 0.05%

PURPOSE

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

High blood pressure
Heart disease
Diabetes
Thyroid diseases
Trouble urinating due to enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

OTC - DO NOT USE SECTION

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 SECTION

Stop use and ask a doctor if symptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast- feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Edetate Disodium, Glycerin, Polyethelene Glycol, Povidone, Propylene Glycol, Sodium Diphospahte Dibasic, Sodium Phosphate Monobasic, Water.

Question or Comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	2
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	2
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OXYMETAZOLINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
20146-4000-2	2025-01-30	C162847	48780-1	9d75b9cf-eea3-f424-e053-dadaa90a57ce	Breaze ® Nasal Spray Moisturizing
20146-4000-2	2023-07-17	C162847	48780-1	9d75b9cf-eea3-f424-e053-dadaa90a57ce	Breaze ® Nasal Spray Moisturizing
20146-4000-2	2020-01-31	C162847	48780-1	9d75b9cf-eea3-f424-e053-dadaa90a57ce	Breaze ® Nasal Spray Moisturizing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
20146-4000-2	Breaze Nasal Moisturizing	1 in 1 CARTON	SPRAY	1		2
20146-4000-2	Breaze Nasal Moisturizing	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
20146-4000	BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]	2	Legacy NDC, 2 package rows	20230718_9a165a12-43d3-4e14-a7ba-bfce579430d6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Oxymetazoline hydrochloride	ACTIVE INGREDIENT	K89MJ0S5VY	1
Oxymetazoline	ACTIVE MOIETY	8VLN5B44ZY	1
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	1
Povidones	INACTIVE INGREDIENT	FZ989GH94E	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	1
Sodium Phosphate, Monobasic, Anhydrous	INACTIVE INGREDIENT	KH7I04HPUU	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Breaze Nasal Moisturizing
Oxymetazoline hydrochloride
Oxymetazoline
Benzalkonium Chloride
Edetate Disodium
Glycerin
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
Propylene Glycol
Sodium Phosphate, Dibasic, Anhydrous
Sodium Phosphate, Monobasic, Anhydrous
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
20146-4000	20146-4000-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Oxymetazoline hydrochloride	K89MJ0S5VY	ACTIB
Benzalkonium Chloride	F5UM2KM3W7	IACT
Edetate Disodium	7FLD91C86K	IACT
Glycerin	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
Propylene Glycol	6DC9Q167V3	IACT
Sodium Phosphate, Dibasic, Anhydrous	22ADO53M6F	IACT
Sodium Phosphate, Monobasic, Anhydrous	KH7I04HPUU	IACT
Water	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 376 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	FILM, SOLUBLE / ORAL	0.05 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET / ORAL		96 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / OPHTHALMIC	1.21 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LIQUID / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	SOLUTION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SHAMPOO, SUSPENSION / TOPICAL	1 %w/v		Exact identifier — unii candidate 41 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / INTRATHECAL		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, FILM COATED / ORAL	0.01 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, SOLUTION / INTRAMUSCULAR	0.62 %w/v		Exact identifier — unii candidate 41 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE, DELAYED RELEASE / ORAL		43 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	18.81 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 41 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SOLUTION / TOPICAL	0.47 %w/v		Exact identifier — unii candidate 41 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	INJECTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	IMPLANT / SUBCUTANEOUS	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / AURICULAR (OTIC)	0 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / SOFT TISSUE		3 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, SUSPENSION / INTRALESIONAL		10 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SOLUTION / OPHTHALMIC	0.78 %w/v		Exact identifier — unii candidate 41 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, FOR SUSPENSION / ORAL		60 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	TABLET, DELAYED RELEASE / ORAL	23.4 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9d8946cd-3361-4f00-b90f-d68e8ca57da1			9a165a12-43d3-4e14-a7ba-bfce579430d6	2022-11-29	Warnings	Exact identifier spl id: 9d8946cd-3361-4f00-b90f-d68e8ca57da1 spl set id: 9a165a12-43d3-4e14-a7ba-bfce579430d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.