Label: CALENDULA cream

  • 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 April 11, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Calendula Officinalis 1X HPUS

  • INDICATIONS & USAGE

    • Helps promote healing of cuts, scrapes, chafing, minor burns and sunburn.

  • DO NOT USE

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

    • Do not use if the tube seal is broken.
  • DOSAGE & ADMINISTRATION

    For minor burns, immediately run cool water on the burn for several minutes and dry. For cuts, scrapes, and chafing, 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

    Version With Disodium EDTA:

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


    Version without Disodium EDTA:

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

  • HOW SUPPLIED

    Tube .5 OZ (14 G)

  • PURPOSE

    Calendula officinalis 1X ... Healing agent

  • STORAGE AND HANDLING

  • QUESTIONS

    Questions, Comments?

    www.BoironCalendula.com

    www.BoironUSA.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Distributed by Boiron Inc.

    6 Campus Boulevard
    Newtown Square, PA

    19073-3267

  • ASK DOCTOR


    Ask a doctor before use in case of deep 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


  • SPL UNCLASSIFIED SECTION

    • Soothes
    • Moisturizes & Heals
    • Paraben-Free
  • WARNINGS

    For external use only. Avoid contact with eyes.

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

  • PRINCIPAL DISPLAY PANEL

    boxboxCalendula Cream box

    Calendula Cream tube

  • INGREDIENTS AND APPEARANCE
    CALENDULA 
    calendula 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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 934 (UNII: Z135WT9208)  
    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)  
    LAUROYL PEG-32 GLYCERIDES (UNII: H5ZC52369M)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-1109-681 in 1 BOX02/29/2016
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/29/2016
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-1109)