Label: CALENDULA- calendula officinalis flowering top 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.

  • PURPOSE

    Calendual officianlis 1X HPUS 4% .... Healing agent

  • INDICATIONS & USAGE

    helps promote healing of: cuts, scrapes, minor burns, temporarily protects and helps relieve chafed, chapped, or cracked skin and lips, helps protect from the drying effects of wind and cold weather

  • DO NOT USE

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

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

  • DOSAGE & ADMINISTRATION

    For minor burns, immediately run cool water on the burn for several minutes and pat dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.

    For cuts, scrapes, and chapped skin, first cleanse the area with mild soap, rinse and dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.

  • INACTIVE INGREDIENT

    alcohol, purified water, white petrolatum USP

  • HOW SUPPLIED

    Tube 1 OZ (30 G)

  • STORAGE AND HANDLING

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


  • 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 19073-3267

  • 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. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING


  • WHEN USING

    When using this product do not get into eyes

  • DRUG INTERACTIONS

    Keep wounds moisturized - Paraben-free - Works naturally with your body

  • WARNINGS

    For external use only

  • SPL UNCLASSIFIED SECTION

    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.

    Soothes & Heals

    Protects Skin

    Plant-Based Relief

    First Aid*

    Cuts, Scrapes, Minor Burns, Chapped Skin*

  • PRINCIPAL DISPLAY PANEL

    labelbox

  • INGREDIENTS AND APPEARANCE
    CALENDULA 
    calendula officinalis flowering top ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-1104
    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
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-1104-5130 g in 1 TUBE; Type 0: Not a Combination Product07/17/1988
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/17/1988
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-1104)