Label: POLYGONATUM CEPA 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 February 28, 2019

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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: Allium cepa (Onion) 2X, Echinacea (Purple coneflower) 2X, Hirudo (Leech) 4X, Polygonatum (Solomon’s seal) 4X, Vespa crabro (Hornet) 6X, Aurum met. (Metallic gold) 8X, Cartilago articularis (Bovine cartilage) 8X, Cuprum met. (Copper) 8X, Cutis (feti) (Porcine skin) 8X, Placenta (bovis) (Bovine placenta) 8X, Quartz (Rock crystal) 8X, Thuja (American arborvitae) 8X, Mesenchyme (Porcine embryonic connective tissue) 10X, Argentum met. (Silver) 12X, Barium citricum (Barium citrate) 12X, Graphites (Foliated crystalline carbon) 17X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Distilled water, Glycerin, Sodium alginate, Rosemary oil, Tea tree oil, Sorbic acid, Grapefruit seed extract

  • PURPOSE

    Uses: Promotes skin regeneration and minimizes scars.

  • 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

    Polygonatum Cepa Gel

  • INGREDIENTS AND APPEARANCE
    POLYGONATUM CEPA 
    polygonatum cepa gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-8358
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION2 [hp_X]  in 1 g
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA2 [hp_X]  in 1 g
    HIRUDIN (UNII: MNY7X23SRZ) (HIRUDIN - UNII:MNY7X23SRZ) HIRUDIN4 [hp_X]  in 1 g
    POLYGONATUM CYRTONEMA ROOT (UNII: W93B56AH6R) (POLYGONATUM CYRTONEMA ROOT - UNII:W93B56AH6R) POLYGONATUM CYRTONEMA ROOT4 [hp_X]  in 1 g
    VESPA CRABRO (UNII: K3ALM8S49H) (VESPA CRABRO - UNII:K3ALM8S49H) VESPA CRABRO6 [hp_X]  in 1 g
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD8 [hp_X]  in 1 g
    BOS TAURUS CARTILAGE (UNII: UE77B10IIY) (BOS TAURUS CARTILAGE - UNII:UE77B10IIY) BOS TAURUS CARTILAGE10 [hp_X]  in 1 g
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER8 [hp_X]  in 1 g
    SUS SCROFA SKIN (UNII: 3EM4VW6TQN) (SUS SCROFA SKIN - UNII:3EM4VW6TQN) SUS SCROFA SKIN8 [hp_X]  in 1 g
    BOS TAURUS PLACENTA (UNII: 83AL37E3A7) (BOS TAURUS PLACENTA - UNII:83AL37E3A7) BOS TAURUS PLACENTA8 [hp_X]  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 [hp_X]  in 1 g
    THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N) THUJA OCCIDENTALIS WHOLE8 [hp_X]  in 1 g
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER12 [hp_X]  in 1 g
    BARIUM CITRATE (UNII: J9X0Y34WC2) (BARIUM - UNII:24GP945V5T) BARIUM CITRATE12 [hp_X]  in 1 g
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE17 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-8358-560 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(48951-8358)
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