GUNA-ORAL SPRAY

Manufacturer: Guna spa
Effective date: 2018-12-21
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 02:11:13

Label at a glance#

ProductGUNA-ORAL

Active ingredientACONITUM NAPELLUS, ARNICA MONTANA, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, WITCH HAZEL, CALCIUM SULFIDE, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, COMFREY ROOT, SUS SCROFA TOOTH

Label structure10 sections

Indications and uses

Temporary relief of symptoms due to inflammation of the oral cavity such as: Sore throat Inflamed gums Pharyngitis

Dosage and administration

Adults and children 12 years and older 2 sprays, 3-5 times per day Children between 12 years and 6 years of age 1 spray t, 3-5 times per day Children under 6 years ask a doctor

Contacts and useful links#

PhoneLabel contact(484) 223-3500

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

ACONITUM NAPELLUS 3X ANTI-INFLAMMATORY

ARNICA MONTANA 3X FEVER RELIEF

BELLADONNA 4X SWELLING

ECHINACEA ANGUSTIFOLIA 2X BACTERIAL INFECTION

ECHINACEA PURPUREA 2X IMMUNE SUPPORT

HAMAMELIS VIRGINIANA 2X SUPPORTS TISSUE REPAIR

HEPAR SULFURIS CALCAREUM 6X ANTIBACTERIAL IMMUNE SUPPORT

HYPERICUM PERFORATUM 3X PAIN RELIEF

MILLEFOLIUM 3X ORAL ANTI- INFLAMMATORY

SYMPHYTUM OFFICINALE 6X ORAL HYPERSENSITIVITY

TEETH 12X TOOTH HYPERSENSITIVITY

USES

OTC - PURPOSE SECTION

Temporary relief of symptoms due to inflammation of the oral cavity such as:

Sore throat
Inflamed gums
Pharyngitis

WARNINGS

WARNINGS SECTION

Stop use and ask doctor if symptoms persist more than 3 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Contains ethyl alcohol 20%

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

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

Children under 6 years ask a doctor

QUESTIONS

OTC - QUESTIONS SECTION

Questions?: info@gunainc.com
Tel. (484) 223-3500

INDICATIONS & USAGE SECTION

Directions: Rotate the nebulizer to the upright position. Spray onto affected areas: mouth, throat or gingiva as needed.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Essential oil of lemon, Essential oil of pine, Ethyl alcohol 20%, Polysorbate-80.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5GOSUS-ORAL SPRAY-Rev07-14-11-18

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17089-452-27	GUNA-ORAL	1 in 1 BOX	SPRAY	1		3
17089-452-27	GUNA-ORAL	50 mL in 1 BOTTLE, SPRAY	SPRAY	50		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17089-452	GUNA-ORAL (ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -) SPRAY [GUNA SPA]	3	Current NDC, Legacy NDC, 2 package rows	20190404_f1b8e5ab-8689-4bf2-a6d9-863d02f29579.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACHILLEA MILLEFOLIUM	ACTIVE INGREDIENT	2FXJ6SW4PK	2
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	2
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	2
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	2
CALCIUM SULFIDE	ACTIVE INGREDIENT	1MBW07J51Q	2
COMFREY ROOT	ACTIVE INGREDIENT	M9VVZ08EKQ	2
ECHINACEA ANGUSTIFOLIA	ACTIVE INGREDIENT	VB06AV5US8	2
ECHINACEA PURPUREA	ACTIVE INGREDIENT	QI7G114Y98	2
HYPERICUM PERFORATUM	ACTIVE INGREDIENT	XK4IUX8MNB	2
SUS SCROFA TOOTH	ACTIVE INGREDIENT	V69U5FL51F	2
WITCH HAZEL	ACTIVE INGREDIENT	101I4J0U34	2
ACHILLEA MILLEFOLIUM	ACTIVE MOIETY	2FXJ6SW4PK	2
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	2
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	2
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	2
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	2
COMFREY ROOT	ACTIVE MOIETY	M9VVZ08EKQ	2
ECHINACEA ANGUSTIFOLIA	ACTIVE MOIETY	VB06AV5US8	2
ECHINACEA PURPUREA	ACTIVE MOIETY	QI7G114Y98	2
HYPERICUM PERFORATUM	ACTIVE MOIETY	XK4IUX8MNB	2
SUS SCROFA TOOTH	ACTIVE MOIETY	V69U5FL51F	2
WITCH HAZEL	ACTIVE MOIETY	101I4J0U34	2
ABIES SACHALINENSIS VAR. SACHALINENSIS OIL	INACTIVE INGREDIENT	9H7TY1ZV7Q	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
LEMON OIL	INACTIVE INGREDIENT	I9GRO824LL	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

GUNA-ORAL
ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -
ACONITUM NAPELLUS
ARNICA MONTANA
ATROPA BELLADONNA
ECHINACEA ANGUSTIFOLIA
ECHINACEA PURPUREA
WITCH HAZEL
CALCIUM SULFIDE
HYPERICUM PERFORATUM
ACHILLEA MILLEFOLIUM
COMFREY ROOT
SUS SCROFA TOOTH
ABIES SACHALINENSIS VAR. SACHALINENSIS OIL
ALCOHOL
LEMON OIL
POLYSORBATE 80

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17089-452	17089-452-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACONITUM NAPELLUS	U0NQ8555JD	ACTIB
ARNICA MONTANA	O80TY208ZW	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
ECHINACEA ANGUSTIFOLIA	VB06AV5US8	ACTIB
ECHINACEA PURPUREA	QI7G114Y98	ACTIB
WITCH HAZEL	101I4J0U34	ACTIB
CALCIUM SULFIDE	1MBW07J51Q	ACTIB
HYPERICUM PERFORATUM	XK4IUX8MNB	ACTIB
ACHILLEA MILLEFOLIUM	2FXJ6SW4PK	ACTIB
COMFREY ROOT	M9VVZ08EKQ	ACTIB
SUS SCROFA TOOTH	V69U5FL51F	ACTIB
ABIES SACHALINENSIS VAR. SACHALINENSIS OIL	9H7TY1ZV7Q	IACT
ALCOHOL	3K9958V90M	IACT
LEMON OIL	I9GRO824LL	IACT
POLYSORBATE 80	6OZP39ZG8H	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 2 · 86 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, LIQUID FILLED / ORAL		24 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii+route 30 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii+dosage form 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii+route 30 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii+route 52 equally ranked IID candidates
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / ORAL		907 mg	Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii+route 30 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		34 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii+route 52 equally ranked IID candidates
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	CAPSULE / ORAL	8.5 mg		Exact identifier — unii+route 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii+route 52 equally ranked IID candidates
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	CAPSULE / ORAL	8.5 mg		Exact identifier — unii+route 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / ORAL		907 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii+route 52 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii+dosage form 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii+route 52 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
GUNA-ORAL	ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -	Guna spa	f1b8e5ab-8689-4bf2-a6d9-863d02f29579	2018-12-21	Warnings	Exact identifier ndc (package): 17089-452-27 ndc (product): 17089-452 ndc11 (package): 17089045227 spl id: 7e8ff906-fbc2-e1bf-e053-2a91aa0a3326 spl set id: f1b8e5ab-8689-4bf2-a6d9-863d02f29579

Reported adverse events (FAERS/openFDA)#

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