Guna-oral Spray

Guna-oral Spray
SPL v3
SPL
SPL Set ID f1b8e5ab-8689-4bf2-a6d9-863d02f29579
Route
ORAL
Published
Effective Date 2018-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (3 [hp_X]) Arnica Montana (4 [hp_X]) Atropa Belladonna (2 [hp_X]) Echinacea Angustifolia (6 [hp_X]) Echinacea Purpurea (12 [hp_X]) Witch Hazel Calcium Sulfide Hypericum Perforatum Achillea Millefolium Comfrey Root Sus Scrofa Tooth
Inactive Ingredients
Abies Sachalinensis Var. Sachalinensis Oil Alcohol Lemon Oil Polysorbate 80

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-05-27

Description

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

Purpose

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


Medication Information

Indications and Usage

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

Purpose

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

Description

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





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

  • Sore throat
  • Inflamed gums
  • Pharyngitis
Section 51727-6

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

Warnings
  • 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

If pregnant or breast-feeding ask a doctor before use

Questions

Questions?: [email protected]

Tel. (484) 223-3500



Directions

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





Principal Display Panel

Active Ingredients/purpose

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






Structured Label Content

Uses (USES)





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

  • Sore throat
  • Inflamed gums
  • Pharyngitis
Indications and Usage (34067-9)

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

Section 51727-6 (51727-6)

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

Warnings (WARNINGS)
  • 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 (PREGNANCY)

If pregnant or breast-feeding ask a doctor before use

Questions (QUESTIONS)

Questions?: [email protected]

Tel. (484) 223-3500



Directions (DIRECTIONS)

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





Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Active Ingredients/purpose (ACTIVE INGREDIENTS/PURPOSE)

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






Advanced Ingredient Data


Raw Label Data

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