Label: D-118- toxicodendron pubescens leaf, punica granatum root bark, arisaema triphyllum root, and kerosene solution

  • 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 June 6, 2022

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  • SPL UNCLASSIFIED SECTION

    NDC 58264-0124-1

  • INDICATIONS

    Temporomandibular joint syndrome (TMJ).

  • INGREDIENTS

    ACTIVE

    Rhus toxicodendron 30x, Granatum 6x, Arum triphyllum 30x, Petroleum 6x

    INACTIVE

    20% alcohol in purified water.

  • SUGGESTED DOSAGE

    One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

  • STORAGE AND HANDLING

    SHAKE WELL

  • Warnings

    • Use only if cap seal is unbroken.

    • If pregnant or breastfeeding, ask a healthcare professional before use.

    • Keep this and all medication out of the reach of children.
  • SPL UNCLASSIFIED SECTION

    To be used according to standard homeopathic indications.

  • PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

    DYNAMIC
    NUTRITIONAL
    ASSOCIATES, INC.

    D 118

    HOMEOPATHIC
    STRESS FORMULA

    1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
  • INGREDIENTS AND APPEARANCE
    D-118 
    toxicodendron pubescens leaf, punica granatum root bark, arisaema triphyllum root, and kerosene solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58264-0124
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 mL
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) (PUNICA GRANATUM ROOT BARK - UNII:CLV24I3T1D) PUNICA GRANATUM ROOT BARK6 [hp_X]  in 1 mL
    ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT30 [hp_X]  in 1 mL
    KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58264-0124-129.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/1990
    Labeler - DNA Labs, Inc. (031784339)
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