Label: OHM MOUTHWASH- arnica montana, borax, calendula officinalis, hypericum perforatum, myrrha, plantago major, ratanhia, salvia officinalis, symphytum officinale. liquid

  • Category: HUMAN PRESCRIPTION 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 January 11, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS): Equal amounts of: Arnica Montana 3X, Borax 3X, Calendula Officinalis 1X, Hypericum Perforatum 3X, Myrrha 3X, Plantago Major 1X, Ratanhia 3X, Salvia Officinalis 1X, Symphytum Officinale 6X.

    * ​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

  • INDICATIONS & USAGE

    USES: Temporarily relieves sensitive, bleeding gums and gingivitis.**

    ​**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

  • WARNINGS

    WARNINGS: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than a week, discontinue use and contact a doctor.

    • ​KEEP OUT OF THE REACH OF CHILDREN.
  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Shake 10 times before use. Adults & children over 12 years old: add 10-15 drops to half a tablespoon of water and rinse the gums for 1 minute. Use 2 times a day, or as directed by a health care professional. Children under 12: use half the adult dose.

  • OTHER SAFETY INFORMATION

    Do not use if cap seal is broken.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Ethanol Alcohol 70% (Non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Purified Water.

  • QUESTIONS

    Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

    www.ohmpharma.com

  • PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC MEDICINE

    NDC: 66096-159-05

    MOUTHWASH

    Natural - Safe - Effective

    No Side Effects

    2 fl oz (59mL) / 70% Alcohol

    PRODUCT OF USA

    2oz bottle label

    Temporarily relieves sensitive, bleeding gums and gingivitis.

  • INGREDIENTS AND APPEARANCE
    OHM MOUTHWASH 
    arnica montana, borax, calendula officinalis, hypericum perforatum, myrrha, plantago major, ratanhia, salvia officinalis, symphytum officinale. liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66096-159
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 59 mL
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE3 [hp_X]  in 59 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 59 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 59 mL
    MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH3 [hp_X]  in 59 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR1 [hp_X]  in 59 mL
    KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT3 [hp_X]  in 59 mL
    SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE1 [hp_X]  in 59 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66096-159-0559 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/15/2015
    Labeler - OHM PHARMA INC. (030572478)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM PHARMA INC.030572478manufacture(66096-159)