Label: CALENDULA 10% 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 May 5, 2021

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

  • INDICATIONS & USAGE

    Directions: FOR TOPICAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Apply to skin as needed. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredient: 100 gm contains: 50 gm Calendula 1X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Distilled water, Organic cane alcohol, Glycerin, Boric acid, Sodium alginate,
    Lavender oil, Sodium hydroxide, Sorbic acid, Tea tree oil, Grapefruit seed extract

  • PURPOSE

    Uses: Temporary relief of minor cuts and wounds.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: FOR EXTERNAL USE ONLY.
    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
    Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist,
    or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes.
    Do not use if safety seal is broken or missing.

  • QUESTIONS

    Questions? Call 866.642.2858
    Made with care by Uriel, East Troy, WI 53120
    www.urielpharmacy.com Lot#

  • PRINCIPAL DISPLAY PANEL

    Calendula 10 Gel

  • INGREDIENTS AND APPEARANCE
    CALENDULA 10% 
    calendula 10% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-4165
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SORBIC ACID (UNII: X045WJ989B)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-4165-560 g in 1 TUBE; Type 0: Not a Combination Product09/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-4165)