Search by Drug Name or NDC

NDC 66492-0004-02 SINUS 12; 4; 6; 6; 6; 2; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

SINUS 12; 4; 6; 6; 6; 2; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

SINUS is a NASAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics. The primary component is CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; ONION; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED.

Product Information

NDC	66492-0004
Product ID	66492-004_d44a03c4-5a56-bf16-e053-2995a90aca66
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SINUS
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pulsatilla, Euphorbium, Allium Cepa, Histaminum, Luffa Operculata, Sabadilla, Hepar Sulfur.
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	NASAL
Active Ingredient Strength	12; 4; 6; 6; 6; 2; 6
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; ONION; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED
Labeler Name	Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 66492-0004-02 (66492000402)

Pricing Information	N/A
NDC Package Code	66492-004-02
Billing NDC	66492000402
Package	30 mL in 1 BOTTLE, SPRAY (66492-004-02)
Marketing Start Date	2017-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6680b1bf-360f-4b98-ac27-9f656de6783e Details

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS:

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED 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.

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Manufactured for:

Be Well Homeopathics Inc.

Miami, Florida 33178

1-877-438-3042

www.bewellhomeo.com

PRINCIPAL DISPLAY PANEL

NDC 66492-004-02

Be Well Homeopathics™

SINUS NASAL SPRAY

30 ml

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

INGREDIENTS AND APPEARANCE

SINUS

pulsatilla, euphorbium, allium cepa, histaminum, luffa operculata, sabadilla, hepar sulfur. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66492-004
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	2 [hp_X] in 1 mL
EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K)	EUPHORBIA RESINIFERA RESIN	4 [hp_X] in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X] in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	6 [hp_X] in 1 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	6 [hp_X] in 1 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	6 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66492-004-02	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/01/2017

Labeler - Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics (052584997)

Revised: 12/2021

Document Id: d44a03c4-5a56-bf16-e053-2995a90aca66

Set id: 6680b1bf-360f-4b98-ac27-9f656de6783e

Version: 4

Effective Time: 20211229

Search by Drug Name or NDC

NDC 66492-0004-02 SINUS 12; 4; 6; 6; 6; 2; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

SINUS 12; 4; 6; 6; 6; 2; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 66492-0004-02 (66492000402)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6680b1bf-360f-4b98-ac27-9f656de6783e Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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