FDA.reportPublic FDA data

Amethyst Rosa

Manufacturer
Uriel Pharmacy, Inc.
Effective date
2023-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:20:57

Label at a glance#

ProductAmethyst Rosa
Active ingredientSILICON DIOXIDE, GRAPHITE, ANTIMONY TRISULFIDE, ACTIVATED CHARCOAL, FUMARIA OFFICINALIS FLOWERING TOP
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, Antimonite (Nat. antimony trisulfide)5x, Carbo betulae (Birch wood charcoal) 2X, Fumaria (Fumitory) 3X, Graphite (Foliated crystalline carbon) 15X.

INACTIVE INGREDIENT SECTION


Inactive Ingredients: Vegetable capsules, Diatomaceous earth, Distilled water, Rose petal extract, Anise oil, Caraway oil
Hematite (Red iron ore), Absinthium (Wormwood), Betula (Borage), Calamus (Sweet flag), Chamomilla (Chamomile), Cochlearia (Common scurvy grass), Gentiana (Yellow gentian), Geum urbanum (Herb bennet), Oxalis (Wood sorrel), Rosa (Garden rose), Urtica dioica (Stinging nettle), Urtica dioica (Stinging nettle), Zingiberis (Ginger), Piper nigrum (Black pepper).

OTC - PURPOSE SECTION

Use: Temporary relief of acne.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

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

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.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1361-7Amethyst Rosa75 g in 1 BOTTLE, GLASSCAPSULE751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1361AMETHYST ROSA CAPSULE [URIEL PHARMACY, INC.]11 package rows20230421_f9c7dc5c-130f-3790-e053-6294a90aa437.zip

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
48951-136148951-1361-7

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
WATER059QF0KO0RIACT
WORMWOODF84709P2XVIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
BLACK PEPPERKM66971LVFIACT
DIATOMACEOUS EARTH2RF6EJ0M85IACT
ACORUS CALAMUS ROOTXY1K7KIQ0FIACT
COCHLEARIA OFFICINALIS FLOWERING TOPM87UN67CKRIACT
GENTIANA LUTEA ROOTS72O3284MSIACT
BETULA PUBESCENS BARK3R504894L9IACT
GINGERC5529G5JPQIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB
URTICA DIOICA ROOTJ8HE8A6E5TIACT
CARAWAY OILC2J9B08Q3IIACT
ROSA RUGOSA FLOWER969IQC5YJUIACT
ANISE OIL6Y89129C8HIACT
GEUM URBANUM ROOT33P1Z2B61FIACT
SEDUM ROSEUM WHOLERH0WP583U3IACT
POWDERED CELLULOSESMD1X3XO9MIACT
GRAPHITE4QQN74LH4OACTIB
CHAMOMILEFGL3685T2XIACT
OXALIS STRICTA WHOLE3STW243384IACT
ANTIMONY TRISULFIDEF79059A38UACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
FUMARIA OFFICINALIS FLOWERING TOPVH659J61ZLACTIB
FERRIC OXIDE RED1K09F3G675IACT

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
f9c7dc5c-1310-3790-e053-6294a90aa437f9c7dc5c-130f-3790-e053-6294a90aa4372023-04-20WarningsExact identifier
spl id: f9c7dc5c-1310-3790-e053-6294a90aa437
spl set id: f9c7dc5c-130f-3790-e053-6294a90aa437

Reported adverse events (FAERS/openFDA)#

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