Label: CALENDULA- calendula officinalis flowering top gel

  • 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 April 7, 2020

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

  • ACTIVE INGREDIENT

    Calendula officinalis 1X

  • INDICATIONS & USAGE

    Helps promote healing of scrapes and skin irritations.

  • DO NOT USE

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

  • DOSAGE & ADMINISTRATION

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

  • INACTIVE INGREDIENT

    Caprylyl glycol, carbomer, dimethicone copolyol, EDTA disodium, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

  • HOW SUPPLIED

    Tube 2.6 OZ (75 G)

  • PURPOSE

    Calendula officinalis 1X ... Healing agent HPUS 7 %

  • 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)

    Boiron Information Center
    6 Campus Boulevard
    Newtown Square, PA 19073-3267

  • ASK DOCTOR

    Consult a doctor in case of deep or puncture wounds, or animal bites.

  • 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

    Non-greasy - Paraben-Free - Quickly absorbed - Cooling effect - 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.

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    CALENDULA 
    calendula officinalis flowering top gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-1108
    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 HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-1108-5975 g in 1 TUBE; Type 0: Not a Combination Product04/13/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/13/1990
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-1108)