Label: AMETHYST ROSA capsule

  • 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 April 10, 2018

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

  • INDICATIONS & USAGE

    Directions: FOR ORAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Take 3-4 times daily. Ages 12 and older: 1-2 capsules. Ages 2-11: 1 capsule. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients: Amethyst (Nat. silicic acid anhydrate with traces of manganese and iron) 2X, Carbo betulae (Birch wood charcoal) 2X, Fumaria (Fumitory) 3X, Absinthium (Wormwood) 4X, Betula (Borage) 4X, Calamus (Sweet flag) 4X, Chamomilla (Chamomile) 4X, Cochlearia (Common scurvy grass) 4X, Gentiana (Yellow gentian) 4X, Geum urbanum (Herb bennet) 4X, Oxalis (Wood sorrel) 4X, Rosa (Garden rose) 4X, Urtica dioica (Stinging nettle) 4X, Urtica dioica (Stinging nettle) 4X, Zingiberis (Ginger) 4X, Antimonite (Nat. antimony trisulfide) 5X, Piper nigrum (Black pepper) 5X, Hematite (Red iron ore) 6X, Graphite (Foliated crystalline carbon) 17X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Vegetable capsules, Diatomaceous earth, Distilled water, Rose petal extract, Anise oil, Caraway oil

  • PURPOSE

    Use: Temporary relief of acne.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: 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 or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. 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

    AmethystRosaCapsules

  • INGREDIENTS AND APPEARANCE
    AMETHYST ROSA 
    amethyst rosa capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1271
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE2 [hp_X]
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL2 [hp_X]
    FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) (FUMARIA OFFICINALIS FLOWERING TOP - UNII:VH659J61ZL) FUMARIA OFFICINALIS FLOWERING TOP3 [hp_X]
    WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV) WORMWOOD4 [hp_X]
    BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) (BETULA PUBESCENS LEAF - UNII:84SOH0O3OO) BETULA PUBESCENS LEAF4 [hp_X]
    ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) (ACORUS CALAMUS ROOT - UNII:XY1K7KIQ0F) ACORUS CALAMUS ROOT4 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA4 [hp_X]
    COCHLEARIA OFFICINALIS FLOWERING TOP (UNII: M87UN67CKR) (COCHLEARIA OFFICINALIS FLOWERING TOP - UNII:M87UN67CKR) COCHLEARIA OFFICINALIS FLOWERING TOP4 [hp_X]
    GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT4 [hp_X]
    GEUM URBANUM ROOT (UNII: 33P1Z2B61F) (GEUM URBANUM ROOT - UNII:33P1Z2B61F) GEUM URBANUM ROOT4 [hp_X]
    OXALIS ACETOSELLA LEAF (UNII: U1W3U02EW0) (OXALIS ACETOSELLA LEAF - UNII:U1W3U02EW0) OXALIS ACETOSELLA LEAF4 [hp_X]
    ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW) (ROSA RUGOSA FLOWER BUD - UNII:TZ0BE8I3MW) ROSA RUGOSA FLOWER BUD4 [hp_X]
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q) (URTICA DIOICA LEAF - UNII:X6M0DRN46Q) URTICA DIOICA LEAF4 [hp_X]
    URTICA DIOICA ROOT (UNII: J8HE8A6E5T) (URTICA DIOICA ROOT - UNII:J8HE8A6E5T) URTICA DIOICA ROOT4 [hp_X]
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER4 [hp_X]
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE5 [hp_X]
    BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER5 [hp_X]
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED6 [hp_X]
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE17 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    WATER (UNII: 059QF0KO0R)  
    ROSA RUGOSA FLOWER (UNII: 969IQC5YJU)  
    ANISE OIL (UNII: 6Y89129C8H)  
    CARAWAY OIL (UNII: C2J9B08Q3I)  
    Product Characteristics
    ColorgrayScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1271-790 in 1 BOTTLE, GLASS; 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(48951-1271)