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NDC 17089-0472-23 GUNA SINUS PLUS 2; 3; 6; 8; 12; 3; 6; 2; 8; 8; 6; 2; 6; 6; 6; 10; 12; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA SINUS PLUS 2; 3; 6; 8; 12; 3; 6; 2; 8; 8; 6; 2; 6; 6; 6; 10; 12; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

GUNA SINUS PLUS is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ALTHAEA OFFICINALIS LEAF; ASCORBIC ACID; CALCIUM SULFIDE; COPPER; DRIMIA MARITIMA BULB; ECHINACEA ANGUSTIFOLIA; HYDRASTIS CANADENSIS WHOLE; LOBARIA PULMONARIA; MANGANESE; MERCURIC SULFIDE; ONION; PLANTAGO MAJOR WHOLE; POTASSIUM DICHROMATE; PULSATILLA VULG.

Product Information

NDC	17089-0472
Product ID	17089-472_b48c5634-24d0-343e-e053-2995a90a3a9a
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	GUNA SINUS PLUS
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALTHAEA OFFICINALIS LEAF - CALCIUM SULFIDE - COPPER - DRIMIA MARITIMA BULB - ECHINACEA ANGUSTIFOLIA - HYDRASTIS CANADENSIS WHOLE - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR WHOLE - POTASSIUM DICHROMATE - PULSATILLA VULGARI
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	NASAL
Active Ingredient Strength	2; 3; 6; 8; 12; 3; 6; 2; 8; 8; 6; 2; 6; 6; 6; 10; 12; 6
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	ALTHAEA OFFICINALIS LEAF; ASCORBIC ACID; CALCIUM SULFIDE; COPPER; DRIMIA MARITIMA BULB; ECHINACEA ANGUSTIFOLIA; HYDRASTIS CANADENSIS WHOLE; LOBARIA PULMONARIA; MANGANESE; MERCURIC SULFIDE; ONION; PLANTAGO MAJOR WHOLE; POTASSIUM DICHROMATE; PULSATILLA VULG
Labeler Name	Guna spa
Pharmaceutical Class	Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhib
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0472-23 (17089047223)

Pricing Information	N/A
NDC Package Code	17089-472-23
Billing NDC	17089047223
Package	1 BOTTLE, SPRAY in 1 BOX (17089-472-23) / 30 mL in 1 BOTTLE, SPRAY
Marketing Start Date	2021-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b48c5634-24cf-343e-e053-2995a90a3a9a Details

DIRECTIONS

Adults and children 12 years and older 2 sprays to each nostril, 3-5 times per day

Children between 12 years and 6 years of age 1 spray to each nostril, 3-5 times per day

Children under 6 years consult a physician

ACTIVE INGREDIENTS/PURPOSE

ALLIUM CEPA 6X, 8X, 12X Relieves hay fever
ALTHEA OFFICINALIS 2X Soothing
ARGENTUM NITRICUM 10X Relieves cold symptoms
ASCORBIC ACIDUM 3X Relieves cold symptoms
ECHINACEA 3X Relieves cold symptoms
HEPAR SULPHURIS CALCAREUM 6X, 8X, 12X Relieves hay fever
HYDRASTIS CANADENSIS 6X, 8X, 12X Relieves mucus buildup
KALI BICHROMICUM 6X, 8X, 12X Relieves mucus buildup
MERCURIUS SOLUBILIS 8X Relieves mucus buildup
MUCOSA NASALIS SUIS 6X, 12X, 30X Relieves stuffy nose
PLANTAGO MAJOR 2X Relieves sinus headache
PULSATILLA 6X, 8X, 12X Relieves sinus headache
SCILLA MARITIMA 12X Relieves nasal discharge
SILICEA 6X, 8X, 12X Relieves runny nose
SINUSITISINUM 12X, 30X Relieves nasal congestion
STICTA PULMONARIA 2X Relieves rhinitis
CUPRUM METALLICUM 8X Supports respiratory organs
MANGANUM METALLICUM 8X Supports respiratory organs

SPL UNCLASSIFIED SECTION

Directions:

tilt head forward slightly, insert the canister tip in the nose, aiming the tip toward the back of the head. Squeeze the pump and spray intro nostril.

SPL UNCLASSIFIED SECTION

Inactive ingredient:purified water, potassium sorbate, sodium benzoate.

QUESTIONS

Questions?: [email protected]

Tel. (484) 223-3500

WARNINGS

Keep out of reach of children.

PREGNANCY

If pregnant or breast-feeding ask a health care profesisonal before use

WARNINGS

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, seek professional assistance or contact a Poison Control Center immediately.

USES

Relieves symptoms of rhinitis and sinusitis such as:

runny nose
headache
mucus buildup
nasal congestion

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA SINUS PLUS

althaea officinalis leaf - calcium sulfide - copper - drimia maritima bulb - echinacea angustifolia - hydrastis canadensis whole - lobaria pulmonaria - manganese - mercuric sulfide - onion - plantago major whole - potassium dichromate - pulsatilla vulgaris - silicon dioxide - silver nitrate - sinusitisinum - sus scrofa nasal mucosa - spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-472
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X] in 30 mL
ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338) (ALTHAEA OFFICINALIS LEAF - UNII:E2QQV92338)	ALTHAEA OFFICINALIS LEAF	2 [hp_X] in 30 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	10 [hp_X] in 30 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	3 [hp_X] in 30 mL
HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T)	HYDRASTIS CANADENSIS WHOLE	6 [hp_X] in 30 mL
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T)	LOBARIA PULMONARIA	2 [hp_X] in 30 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	8 [hp_X] in 30 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X] in 30 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_X] in 30 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_X] in 30 mL
MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P)	MANGANESE	8 [hp_X] in 30 mL
MERCURIC SULFIDE (UNII: ZI0T668SF1) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC SULFIDE	8 [hp_X] in 30 mL
SUS SCROFA NASAL MUCOSA (UNII: ID3Z1X61WY) (SUS SCROFA NASAL MUCOSA - UNII:ID3Z1X61WY)	SUS SCROFA NASAL MUCOSA	6 [hp_X] in 30 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X] in 30 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	6 [hp_X] in 30 mL
SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5)	SINUSITISINUM	12 [hp_X] in 30 mL
PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR WHOLE - UNII:W2469WNO6U)	PLANTAGO MAJOR WHOLE	2 [hp_X] in 30 mL
DRIMIA MARITIMA BULB (UNII: 3629601H5D) (DRIMIA MARITIMA BULB - UNII:3629601H5D)	DRIMIA MARITIMA BULB	12 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.03 mL in 30 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.03 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-472-23	1 in 1 BOX	02/17/2021
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/17/2021

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-472)

Revised: 2/2021

Document Id: b48c5634-24d0-343e-e053-2995a90a3a9a

Set id: b48c5634-24cf-343e-e053-2995a90a3a9a

Version: 1

Effective Time: 20210217

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Product Information

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NDC 17089-0472-23 (17089047223)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b48c5634-24cf-343e-e053-2995a90a3a9a Details

DIRECTIONS

ACTIVE INGREDIENTS/PURPOSE

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

QUESTIONS

WARNINGS

PREGNANCY

WARNINGS

USES

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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