FDA.reportPublic FDA data

Amber Amethyst

Manufacturer
Uriel Pharmacy, Inc
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:36:48

Label at a glance#

ProductAmber Amethyst
Active ingredientHORSE CHESTNUT, AMBER, EQUISETUM ARVENSE WHOLE, SILICON DIOXIDE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Apply to skin on and around the neck and jaw area as needed. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 100 gm contains: 4 gm Aesculus (Horse chestnut) 2X, 4 gm Equisetum (Common horsetail) 2X; Amber (Fossilized tree resin) 3X, Amethyst (Nat. silicic acid anhydrate with traces of manganese and iron) 6X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Olive oil, Peat extract, Lanolin, Sunflower seed oil, Water, Beeswax, Lanolin alcohol, Lavender oil, Tea tree oil, Frankincense oil, Myrrh oil

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Use: Temporary relief of teething pain.

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. Contains traces of lactose. 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.

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

Amber Amethyst OintmentAmber Amethyst Ointment

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1408-5Amber Amethyst60 g in 1 TUBEOINTMENT601

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-140848951-1408-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
TEA TREE OILVIF565UC2GIACT
FRANKINCENSE OIL67ZYA5T02KIACT
HORSE CHESTNUT3C18L6RJAZACTIB
SPHAGNUM SQUARROSUM PEATZ7G226H5SAIACT
SUNFLOWER OIL3W1JG795YIIACT
WATER059QF0KO0RIACT
BEESWAX2ZA36H0S2VIACT
LANOLIN ALCOHOL884C3FA9HEIACT
LAVENDER OILZBP1YXW0H8IACT
OLIVE OIL6UYK2W1W1EIACT
AMBER70J9Z0J26PACTIB
EQUISETUM ARVENSE WHOLE73DM367W4PACTIB
MYRRH OILH74221J5J4IACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB

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
Amber AmethystAMBER AMETHYSTUriel Pharmacy, Inc4837e805-a777-c1fa-e063-6294a90ae9c42026-01-12WarningsExact identifier
ndc (package): 48951-1408-5
ndc (product): 48951-1408
ndc11 (package): 48951140805
spl id: 4837e805-a778-c1fa-e063-6294a90ae9c4
spl set id: 4837e805-a777-c1fa-e063-6294a90ae9c4

Reported adverse events (FAERS/openFDA)#

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