Label: GUM THERAPY- calendula officinalis, eugenia caryophyllata, plantago major, arnica montana, phytolacca decandra, phosphorus, peptostreptococcus anaerobius, carbo vegetabilis, hepar sulphuris calcareum, lachesis mutus, mercurius solubilis 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 September 12, 2022

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  • ACTIVE INGREDIENTS:

    Calendula Officinalis 1X, Eugenia Caryophyllata 1X, Plantago Major 1X, Arnica Montana 3X, Phytolacca Decandra 8X, Phosphorus 12X, Peptostreptococcus Anaerobius 15X, 30X, Carbo Vegetabilis 30C, Hepar Sulphuris Calcareum 30C, Lachesis Mutus 30C, Mercurius Solubilis 30C.

  • HOMEOPATHIC INDICATIONS:

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

    **These statements are based upon traditional 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 physician or Poison Control Center right away.

    If pregnant or breast-feeding, seek advice of 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:

    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.

  • HOMEOPATHIC INDICATIONS:

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

    **These statements are based upon traditional 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 43742-1244-1
    HOMEOPATHIC
    GUM
    THERAPY
    1 FL OZ (30 ml)

    Gum Therapy

  • INGREDIENTS AND APPEARANCE
    GUM THERAPY 
    calendula officinalis, eugenia caryophyllata, plantago major, arnica montana, phytolacca decandra, phosphorus, peptostreptococcus anaerobius, carbo vegetabilis, hepar sulphuris calcareum, lachesis mutus, mercurius solubilis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43742-1244
    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
    CLOVE (UNII: K48IKT5321) (CLOVE - UNII:K48IKT5321) CLOVE1 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR1 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT8 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    PEPTOSTREPTOCOCCUS ANAEROBIUS (UNII: YQI5QWB9DU) (PEPTOSTREPTOCOCCUS ANAEROBIUS - UNII:YQI5QWB9DU) PEPTOSTREPTOCOCCUS ANAEROBIUS15 [hp_X]  in 1 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL30 [hp_C]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_C]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_C]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43742-1244-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/10/201808/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/10/201808/01/2024
    Labeler - Deseret Biologicals (940741853)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43742-1244) , api manufacture(43742-1244) , label(43742-1244) , pack(43742-1244)
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