Label: CALENDULA- calendula officinalis flowering top cream

  • NDC Code(s): 0220-1109-63, 0220-1109-68
  • Packager: Laboratoires Boiron
  • 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 May 12, 2020

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

  • ACTIVE INGREDIENT

    Calendula officinalis 1X

  • INDICATIONS & USAGE

    Helps promote healing of  minor burns and cuts, scrapes, skin irritations and sunburn.

  • DO NOT USE

    Do not use if glued carton en flaps are open or if the tube seal is broken.

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

  • DOSAGE & ADMINISTRATION

    For minor burns, immediately run coll water on the burn for several minutes and dry. For scrapes and skin irritations, first cleanse the area with mild soap, rinse and dry.
    Then apply a thin layer of Calendula cream to affected area 3 times a day or as needed.

  • INACTIVE INGREDIENT

    Calendula Cream:

    Caprylyl glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

    Calendula Cream (without disodium EDTA)

    Caprylyl glycol, carbomer, cetyl palmitate, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

  • HOW SUPPLIED

    Tube 2.6 OZ (70 G)

    Tube 0.5 OZ (14 G)

  • PURPOSE

    Calendula officinalis 1X ... Healing agent HPUS 10 %

  • STORAGE AND HANDLING

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

  • QUESTIONS

    Questions, Comments?

    www.boironusa.com

    info@boironusa.com

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



    Distributed by Boiron, Inc.
    Newtown Square, PA 19073-3267

  • ASK DOCTOR

    Consult a doctor 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING


  • WHEN USING


  • DRUG INTERACTIONS

    Moisturizing - Paraben-Free - Ideal for sensitive skin - Works naturally with your body

  • WARNINGS

    For external use only
    Avoid contact with eyes.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • SPL UNCLASSIFIED SECTION

    Homoepathic 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 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-1109
    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
    HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-1109-6370 g in 1 TUBE; Type 0: Not a Combination Product03/21/2006
    2NDC:0220-1109-681 in 1 BOX02/29/2016
    214 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/21/2006
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-1109)