Label: CALENDULA OFFICINALIS pellet

  • Category: HUMAN OTC DRUG LABEL

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 December 30, 2021

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  • ACTIVE INGREDIENT

    DRUG FACTS: ACTIVE INGREDIENTS: CALENDULA OFFICINALS

    CONTENT: Approx. 100 Pellets

  • INDICATIONS & USAGE

    USE: To be used according to standard homeopathic indications.

  • WARNINGS

    WARNINGS: Keep out of reach of children. If pregnant or breast-feeding, ask a health care professional before use. Stop use and ask a health care professional if symptoms persist for more than 3 days or worsen.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Dissolve 3-5 pellets under the tongue 3 times a day or as directed by a professional.

  • OTHER SAFETY INFORMATION

    OTHER INFORMATION: Store at room temperature. Do not use if pellet dispenser seal is broken.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Organic sucrose, lactose free.

  • QUESTIONS

    Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS). PRODUCT OF USA.

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

    www.ohmpharma.com FDA Est # 3003231743

  • PRINCIPAL DISPLAY PANEL

    CALENDULA OFFICINALIS

    The OTC Potency range from Calendula Officinalis 6X-30X, 3C-30C, 200C, 1M.

    Standard bottle sizes for dilution-form can range from 30mL to 60mL.

    MD Tube Label

    To be used according to standard homeopathic indications.

  • INGREDIENTS AND APPEARANCE
    CALENDULA OFFICINALIS 
    calendula officinalis pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66096-807
    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 TOP6 [hp_C]  in 6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66096-807-016 [hp_C] in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2019
    Labeler - OHM PHARMA INC. (030572478)
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