Label: CALENDULA 10 cream

  • 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 July 23, 2014

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  • INDICATIONS & USAGE

    Directions: FOR TOPICAL USE ONLY.

  • DOSAGE & ADMINISTRATION

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

  • ACTIVE INGREDIENT

    Active Ingredient: 100gm contains: 10 gm Calendula ex herba 1X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Distilled water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Potassium sorbate, Frankincense oil, Myrrh oil, Grapefruit seed extract

  • PURPOSE

    Uses: Temporary relief of minor scrapes and cuts.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: FOR EXTERNAL USE ONLY. 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

  • PRINCIPAL DISPLAY PANEL

    product label

  • INGREDIENTS AND APPEARANCE
    CALENDULA 10 
    calendula 10 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-3009
    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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    MYRRH OIL (UNII: H74221J5J4)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-3009-560 g in 1 TUBE
    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(48951-3009)
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