Label: CALENDULA COMBINATION 9260- calendula combination 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 August 15, 2019

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  • ACTIVE INGREDIENTS

    Bellis perennis 2X
    Calendula officinalis 2X
    Echinacea angustifolia 2X
    Hamamelis virginiana 2X
    Aconitum napellus 3X
    Arnica montana 3X
    Chamomilla 3X
    Hypericum perforatum 3X
    Millefolium 3X
    Belladonna 4X
    Hepar sulphuris calcareum 5X
    Symphytum officinale 6X
    Carbo vegetabilis 12X
    Mercurius solubilis 12X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of mild pain, bruising, or swelling associated with minor injuries or wounds.*

  • PURPOSE

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS

    If symptoms do not improve or are accompanied by a fever, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

    Keep out of the reach of children.

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

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    40% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Calendula Combination

    Homeopathic Remedy

    1 FL. OZ. (29.5 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    CALENDULA COMBINATION  9260
    calendula combination liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-9260
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS WHOLE - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE2 [hp_X]  in 29.5 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]  in 29.5 mL
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE2 [hp_X]  in 29.5 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]  in 29.5 mL
    ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE3 [hp_X]  in 29.5 mL
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE3 [hp_X]  in 29.5 mL
    ARTEMISIA ANNUA FLOWERING TOP (UNII: 0UQK6O82OW) (ARTEMISIA ANNUA FLOWERING TOP - UNII:0UQK6O82OW) ARTEMISIA ANNUA FLOWERING TOP3 [hp_X]  in 29.5 mL
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM WHOLE - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE3 [hp_X]  in 29.5 mL
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM WHOLE - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM WHOLE3 [hp_X]  in 29.5 mL
    AMARYLLIS BELLADONNA WHOLE (UNII: 11B89M58UN) (AMARYLLIS BELLADONNA WHOLE - UNII:11B89M58UN) AMARYLLIS BELLADONNA WHOLE4 [hp_X]  in 29.5 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE5 [hp_X]  in 29.5 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 29.5 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 29.5 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 29.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-9260-129.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-9260)
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