FDA.reportPublic FDA data

Amethyst Rosa

Manufacturer
Uriel Pharmacy, Inc.
Effective date
2022-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:52:32

Label at a glance#

ProductAmethyst Rosa
Active ingredientSILICON DIOXIDE, WORMWOOD, ACTIVATED CHARCOAL, FUMARIA OFFICINALIS FLOWERING TOP, BETULA PUBESCENS BARK, ACORUS CALAMUS ROOT, GENTIANA LUTEA ROOT, GEUM URBANUM ROOT, CHAMOMILE, GINGER, FERRIC OXIDE RED, OXALIS STRICTA WHOLE, SEDUM ROSEUM WHOLE, URTICA DIOICA LEAF, BLACK PEPPER, GRAPHITE, COCHLEARIA OFFICINALIS FLOWERING TOP, ANTIMONY TRISULFIDE, URTICA DIOICA ROOT
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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 SECTION

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

OTC - PURPOSE SECTION

Use: Temporary relief of acne.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

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.

Allergen Statement: This product was produced on equipment that also processes products that contain lactose.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Amethyst Rosa CapsulesAmethyst Rosa Capsules

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-135748951-1357-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
WORMWOODF84709P2XVACTIB
ROSA RUGOSA FLOWER969IQC5YJUIACT
ANISE OIL6Y89129C8HIACT
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
FUMARIA OFFICINALIS FLOWERING TOPVH659J61ZLACTIB
BETULA PUBESCENS BARK3R504894L9ACTIB
ACORUS CALAMUS ROOTXY1K7KIQ0FACTIB
GENTIANA LUTEA ROOTS72O3284MSACTIB
GEUM URBANUM ROOT33P1Z2B61FACTIB
CHAMOMILEFGL3685T2XACTIB
GINGERC5529G5JPQACTIB
FERRIC OXIDE RED1K09F3G675ACTIB
WATER059QF0KO0RIACT
CARAWAY OILC2J9B08Q3IIACT
OXALIS STRICTA WHOLE3STW243384ACTIB
SEDUM ROSEUM WHOLERH0WP583U3ACTIB
POWDERED CELLULOSESMD1X3XO9MIACT
URTICA DIOICA LEAFX6M0DRN46QACTIB
BLACK PEPPERKM66971LVFACTIB
GRAPHITE4QQN74LH4OACTIB
COCHLEARIA OFFICINALIS FLOWERING TOPM87UN67CKRACTIB
DIATOMACEOUS EARTH2RF6EJ0M85IACT
ANTIMONY TRISULFIDEF79059A38UACTIB
URTICA DIOICA ROOTJ8HE8A6E5TACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
05b71fd3-71ac-866b-e063-6294a90aa9afea238544-ece2-1201-e053-2995a90a7d422023-09-19WarningsExact identifier
spl set id: ea238544-ece2-1201-e053-2995a90a7d42

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.