Label: CALENDULA ointment

  • 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 September 29, 2020

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

  • ACTIVE INGREDIENT

    Calendula Officinalis 1X HPUS 4%

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • INDICATIONS & USAGE

    • Temporarily protects and helps promote healing of minor burns.

  • DO NOT USE

    Do not use

    • Over large areas of the body
    • If you are allergic to Calendula officinalis or to this product's inactive ingredients.
    • Under tight bandages.
    • Do not use if glued carton end flaps are broken or if the tube seal is broken.
  • DOSAGE & ADMINISTRATION

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

    • Then apply a thin layer of Calendula Burn to affected area 3 times a day or as needed.

  • INACTIVE INGREDIENT

    White petrolatum USP, alcohol, purfied water

  • HOW SUPPLIED

    Tube 1 OZ (30 G)

  • PURPOSE

    Calendula officinalis 1X HPUS 4%... Healing agent

  • STORAGE AND HANDLING

    Store below 68-77° F (20-25° C)

  • QUESTIONS

    Questions, Comments?

    BoironCalendula.com

    BoironUSA.com
    info@boiron.com

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

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

  • ASK DOCTOR



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

    • bisters
    • thickening of the skin
    • white and leathery appearance.
  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING

  • SPL UNCLASSIFIED SECTION

    Soothes & Heals

    Protects Skin

    Plant-based relief

    No fragrances, dyes or parabens

    For all ages

    Burn Relief*

    Minor Burns*

    ɨ 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.

  • 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

    labelCalendula Burn box

    Calendula Burn tube

  • INGREDIENTS AND APPEARANCE
    CALENDULA 
    calendula ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9086
    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
    ALCOHOL (UNII: 3K9958V90M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9086-511 in 1 BOX01/29/2016
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/29/2016
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9086)