FDA.reportPublic FDA data

SINUS NASAL SPRAY

Manufacturer
Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:22

Label at a glance#

ProductSINUS
Active ingredientPULSATILLA VULGARIS, EUPHORBIA RESINIFERA RESIN, ONION, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SCHOENOCAULON OFFICINALE SEED, CALCIUM SULFIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

Pulsatilla 2X, Euphorbium 4X, Allium Cepa 6X, Histaminum 6X, Luffa Operculata 6X, Sabadilla 6X, Hepar Sulfur 12X

INDICATIONS & USAGE SECTION

INDICATIONS: For the temporary relief of acute and chronic rhinitis, sinusitis and hayfever.

WARNINGS SECTION

WARNINGS:

If symptoms persist or worsen, a health professional should be consulted. As with any drug, if you are pregnant or nursing seek the advice of your physician before using the product.

KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

DOSAGE: 1 spray in each nostril three to eight times daily.

OTHER SAFETY INFORMATION

TAMPER EVIDENT: There is a safety seal on the neck and cap of the bottle. Do not use this product if the safety seal is broken or missing.

Store tightly closed, protect from excessive heat, light and moisture.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Demineralized Water, Sodium Chloride, Benzalkonium Chloride.

OTC - QUESTIONS SECTION

Manufactured for:

Be Well Homeopathics Inc.

Miami, Florida 33178

1-877-438-3042

www.bewellhomeo.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66492-004-02

Be Well Homeopathics™

SINUS NASAL SPRAY

30 ml

1oz bottle label1oz bottle label

OTC - PURPOSE SECTION

Temporary relief of acute and chronic rhinitis, sinusitis and hayfever.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66492-004-02SINUS30 mL in 1 BOTTLE, SPRAYLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66492-004SINUS (PULSATILLA, EUPHORBIUM, ALLIUM CEPA, HISTAMINUM, LUFFA OPERCULATA, SABADILLA, HEPAR SULFUR.) LIQUID [BE WELL MEDICAL DBA RICHARD CLEMENT NUTRITION Y BE WELL HOMEOPATHICS]4Current NDC, Legacy NDC, 1 package rows20211230_6680b1bf-360f-4b98-ac27-9f656de6783e.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66492-00466492-004-02

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
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
PULSATILLA VULGARISI76KB35JEVACTIB
EUPHORBIA RESINIFERA RESIN1TI1O9028KACTIB
ONION492225Q21HACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
LUFFA OPERCULATA FRUITC4MO6809HUACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
CALCIUM SULFIDE1MBW07J51QACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SINUSPULSATILLA, EUPHORBIUM, ALLIUM CEPA, HISTAMINUM, LUFFA OPERCULATA, SABADILLA, HEPAR SULFUR.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics6680b1bf-360f-4b98-ac27-9f656de6783e2021-12-29WarningsExact identifier
ndc (package): 66492-004-02
ndc (product): 66492-004
ndc11 (package): 66492000402
spl id: d44a03c4-5a56-bf16-e053-2995a90aca66
spl set id: 6680b1bf-360f-4b98-ac27-9f656de6783e

Reported adverse events (FAERS/openFDA)#

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