Label: AQUILINUM TARAXACUM 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 November 16, 2018

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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 Ingredients: Chelidonium (Greater celandine) 3X, Filix (Male fern) 3X, Pteridium (Eagle fern) 3X, Salix purp. (Purple willow) 3X, Salix vim. (Osier willow) 3X, Salix vite. (Golden willow) 3X, Scolopendrium (Hart’s tongue) 3X, Solidago virg. (Goldenrod) 3X, Taraxacum (Dandelion) 3X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Distilled water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Steryl alcohol, Xanthan gum, Frankincense oil, Myrrh oil, Sorbic acid, Tea tree oil, Grapefruit seed extract

  • PURPOSE

    Use: Temporary relief of digestive upset.

  • 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

  • PRINCIPAL DISPLAY PANEL

    Aquilinum Taraxacum Cream

  • INGREDIENTS AND APPEARANCE
    AQUILINUM TARAXACUM 
    aquilinum taraxacum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM PALUSTRE ROOT (UNII: GCZ4W7077C) (TARAXACUM PALUSTRE ROOT - UNII:GCZ4W7077C) TARAXACUM PALUSTRE ROOT3 [hp_X]  in 1 g
    ASPLENIUM SCOLOPENDRIUM TOP (UNII: HJA3YWQ7HL) (ASPLENIUM SCOLOPENDRIUM TOP - UNII:HJA3YWQ7HL) ASPLENIUM SCOLOPENDRIUM TOP3 [hp_X]  in 1 g
    WILLOW BARK (UNII: S883J9JDYX) (WILLOW BARK - UNII:S883J9JDYX) WILLOW BARK3 [hp_X]  in 1 g
    DRYOPTERIS FILIX-MAS ROOT (UNII: C0ZK0RRF5X) (DRYOPTERIS FILIX-MAS ROOT - UNII:C0ZK0RRF5X) DRYOPTERIS FILIX-MAS ROOT3 [hp_X]  in 1 g
    SOLIDAGO CANADENSIS FLOWERING TOP (UNII: ZHL562L3PR) (SOLIDAGO CANADENSIS FLOWERING TOP - UNII:ZHL562L3PR) SOLIDAGO CANADENSIS FLOWERING TOP3 [hp_X]  in 1 g
    PTERIDIUM AQUILINUM WHOLE (UNII: 05T3M06HCM) (PTERIDIUM AQUILINUM WHOLE - UNII:05T3M06HCM) PTERIDIUM AQUILINUM WHOLE3 [hp_X]  in 1 g
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 g
    SALIX PURPUREA BARK (UNII: 287VJO13M9) (SALIX PURPUREA BARK - UNII:287VJO13M9) SALIX PURPUREA BARK3 [hp_X]  in 1 g
    SALIX ALBA FLOWER (UNII: 905Y746BSW) (SALIX ALBA FLOWER - UNII:905Y746BSW) SALIX ALBA FLOWER3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MYRRH OIL (UNII: H74221J5J4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1311-560 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(48951-1311)
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