Label: ANTI FUNGAL- baptisia tinctoria, calendula officinalis, thuja occidentalis. 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 January 11, 2021

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

  • ACTIVE INGREDIENT

    AVTIVE INGREDIENTS (HPUS*): Equal amounts of: Baptisia Tinctoria 1X, Calendula Officinalis 1X, Thuja Occidentalis 1X.

    ​*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 skin and nail fungal infections. Warts, Athletes foot.**

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

  • WARNINGS

    WARNINGS: FOR EXTERNAL USE ONLY.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 REACH OF CHILDREN.
  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Apply 5 drops to affected area 3 times a day, as needed, or as directed by a health care professional. Do not apply to open wounds due to alcohol content or dilute in water when necessary.

  • 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), Glycerin, Purified Water.

  • QUESTIONS

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

    www.ohmpharma.com

  • PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC MEDICINE

    NDC: 66096-143-02

    ANTI-FUNGAL

    Natural - Safe - Effective

    No Side Effects

    1 fl oz (30mL) / 70% Alcohol

    PRODUCT OF USA

    1oz bottle label

    Temporarily relieves skin and nail fungal infections.

  • INGREDIENTS AND APPEARANCE
    ANTI FUNGAL 
    baptisia tinctoria, calendula officinalis, thuja occidentalis. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66096-143
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT1 [hp_X]  in 30 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 30 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG1 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66096-143-0230 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/10/2016
    Labeler - OHM PHARMA INC. (030572478)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM PHARMA INC.030572478manufacture(66096-143)