Label: CALENDULA- calendula officinalis flowering top gel

  • 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 October 24, 2019

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

  • ACTIVE INGREDIENT

    Calendula officinalis 1X

  • PURPOSE

    Calendula officinalis 1X ... Healing agent HPUS 7 %

  • INDICATIONS & USAGE

    Helps promote healing of skin irritations such as: rashes, razor burns, insect bites or stings

  • WARNINGS

    For external use only

    Avoid contact with eyes.

  • ASK DOCTOR

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

  • STOP USE

    Stop use and ask doctor if condition persists for more than 3 days or worsens.

  • PREGNANCY OR BREAST FEEDING


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DO NOT USE

    Do not use if you are allergic to Calendula officinalis or to any of this product's inactive ingredients.

  • DOSAGE & ADMINISTRATION

    First cleanse the area with mild soap, rinse and dry. Then apply a thin layer of Calendula Gel to affected area 3 times a day or as needed.

  • INACTIVE INGREDIENT

    Caprylyl glycol, carbomer, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

  • QUESTIONS

    Questions, Comments?

    BoironCalendula.com

    BoironUSA.com

    info@boironusa.com

    1-800-BOIRON-1 (1-800-264-7661)

    Distributed by Boiron, Inc.

    Newtown Square, PA 19073

    Made in France

  • SPL UNCLASSIFIED SECTION

    Net Weight 1.5 oz. (45g)

    Do not use if glued carton end flaps are open or if the tube seal is broken,

    Store at 68-77 o F (20-25 o C)

    The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Phatmacopoeia of the United States.

    Natural Active Ingredient 'Homeopathic mother tincture made from Calendula officinalis flowering tops.
    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

    **C, K, CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CALENDULA 
    calendula officinalis flowering top gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-1105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-1105-5445 g in 1 TUBE; Type 0: Not a Combination Product09/30/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/30/1993
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-1105)