Label: 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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 21, 2018

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  • 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


  • USES



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

    • Sore throat
    • Inflamed gums
    • Pharyngitis
  • 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

  • WARNINGS

    Keep out of reach of children

  • 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


  • QUESTIONS

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

  • INDICATIONS & USAGE

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

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

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

  • INGREDIENTS AND APPEARANCE
    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
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-452
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 30 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 30 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]  in 30 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA2 [hp_X]  in 30 mL
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]  in 30 mL
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL2 [hp_X]  in 30 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_X]  in 30 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 30 mL
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM3 [hp_X]  in 30 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 30 mL
    SUS SCROFA TOOTH (UNII: V69U5FL51F) (SUS SCROFA TOOTH - UNII:V69U5FL51F) SUS SCROFA TOOTH12 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ABIES SACHALINENSIS VAR. SACHALINENSIS OIL (UNII: 9H7TY1ZV7Q)  
    ALCOHOL (UNII: 3K9958V90M)  
    LEMON OIL (UNII: I9GRO824LL)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-452-271 in 1 BOX12/21/2018
    150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/27/2010
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-452)
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