Label: GUM THERAPY- calendula officinalis, kali phosphoricum, natrum muriaticum, arnica montana, borax, cistus canadensis, kreosotum, myrrha, calcarea fluorica, aconitum napellus, bismuthum subnitricum, sepia, hepar sulphuris calcareum, mercurius vivus liquid

  • 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 July 19, 2023

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  • ACTIVE INGREDIENTS:

    Calendula Officinalis 1X, 6X, 12X, 30X, Kali Phosphoricum 3X, Natrum Muriaticum 3X, Arnica Montana 3X, 6X, 12X, 30X, Borax 6X, Cistus Canadensis 6X, Kreosotum 6X, Myrrha 6X, Calcarea Fluorica 8X, Aconitum Napellus 12X, Bismuthum Subnitricum 12X, Sepia 12X, Hepar Sulphuris Calcareum 12X, 18X, 30X, Mercurius Vivus 12X, 18X, 30X.

  • PURPOSE:

    For temporary relief of symptoms related to inflamed and bleeding gums and minor pain.**

    **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS:

    Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

    If pregnant or breast-feeding, ask a health professional before use.

    Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN:

    In case of overdose, contact physician or Poison Control Center right away.

  • DIRECTIONS:

    1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of symptoms related to inflamed and bleeding gums and minor pain.**

    **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Dist. By: Deseret Biologicals, Inc.

    469 W. Parkland Drive

    Sandy, UT 84070 www.desbio.com

  • PACKAGE LABEL DISPLAY:

    DESBIO
    NDC 43742-2088-1
    HOMEOPATHIC
    GUM
    THERAPY
    1 FL OZ (30 ml)

    GUM THERAPY

  • INGREDIENTS AND APPEARANCE
    GUM THERAPY 
    calendula officinalis, kali phosphoricum, natrum muriaticum, arnica montana, borax, cistus canadensis, kreosotum, myrrha, calcarea fluorica, aconitum napellus, bismuthum subnitricum, sepia, hepar sulphuris calcareum, mercurius vivus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43742-2088
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 mL
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE3 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE3 [hp_X]  in 1 mL
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE3 [hp_X]  in 1 mL
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE6 [hp_X]  in 1 mL
    HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3) HELIANTHEMUM CANADENSE6 [hp_X]  in 1 mL
    WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE6 [hp_X]  in 1 mL
    MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH6 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE8 [hp_X]  in 1 mL
    ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE12 [hp_X]  in 1 mL
    BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43742-2088-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/19/2023
    Labeler - Deseret Biologicals (940741853)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43742-2088) , api manufacture(43742-2088) , label(43742-2088) , pack(43742-2088)
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