Label: BETULA RHUS SPECIAL ORDER cream

  • Category: HUMAN OTC DRUG LABEL

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 14, 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: Betula cort. decoct. (Silver birch, bark dried) 2X, Salix (Willow) 2X, Spiraea ulmaria (Meadowsweet) 2X, Urtica urens (Small nettle) 2X, Acidum benzoicum (Benzoic acid) 3X, Berberis (Barberry) 4X, Colchicum (Meadow saffron) 5X, Formica (Red wood ant) 10X, Rhus tox. (Sumac) 12X

  • INACTIVE INGREDIENT

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

  • PURPOSE

    Use: Temporary relief of sore muscles.

  • 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

    Betula Rhus Special Order Cream

  • INGREDIENTS AND APPEARANCE
    BETULA RHUS SPECIAL ORDER 
    betula rhus special order cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-2114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9) BETULA PUBESCENS BARK2 [hp_X]  in 1 g
    SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE2 [hp_X]  in 1 g
    FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) (FILIPENDULA ULMARIA ROOT - UNII:997724QNDS) FILIPENDULA ULMARIA ROOT2 [hp_X]  in 1 g
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS2 [hp_X]  in 1 g
    BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID3 [hp_X]  in 1 g
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK4 [hp_X]  in 1 g
    COLCHICUM AUTUMNALE WHOLE (UNII: W79255C628) (COLCHICUM AUTUMNALE WHOLE - UNII:W79255C628) COLCHICUM AUTUMNALE WHOLE5 [hp_X]  in 1 g
    FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA10 [hp_X]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    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)  
    SORBIC ACID (UNII: X045WJ989B)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    MYRRH OIL (UNII: H74221J5J4)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-2114-560 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(48951-2114)
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