CALENDULA OINTMENT [BOIRON]

CALENDULA OINTMENT [BOIRON]
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NDC 0220-9086-51
Set ID 28c76b61-2a0c-0f52-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Boiron
Generic Name
Product Class
Product Number
Application Number
  • 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)

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