Amber Amethyst
- Manufacturer
- Uriel Pharmacy Inc.
- Effective date
- 2024-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:29:20
Label at a glance#
Contacts and useful links#
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: Spring water, Peat extract, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Sorbic acid, Tea tree oil, Frankincense oil, Grapefruit seed extract, Myrrh oil
Prepared using rhythmical processes.
OTC - PURPOSE SECTION
Use: Temporary relief of teething pain.
WARNINGS SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN.
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
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48951-1270-5 | Amber Amethyst | 60 g in 1 TUBE | CREAM | 60 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48951-1270 | AMBER AMETHYST CREAM [URIEL PHARMACY INC.] | 4 | Legacy NDC, 1 package rows | 20241207_8f0cebad-895e-494d-9112-a0a8ab09ea44.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AMBER | ACTIVE INGREDIENT | 70J9Z0J26P | 1 | |
| COLLOIDAL SILICON DIOXIDE | ACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| EQUISETUM ARVENSE TOP | ACTIVE INGREDIENT | 1DP6Y6B65Z | 1 | |
| HORSE CHESTNUT | ACTIVE INGREDIENT | 3C18L6RJAZ | 1 | |
| AMBER | ACTIVE MOIETY | 70J9Z0J26P | 1 | |
| COLLOIDAL SILICON DIOXIDE | ACTIVE MOIETY | ETJ7Z6XBU4 | 1 | |
| EQUISETUM ARVENSE TOP | ACTIVE MOIETY | 1DP6Y6B65Z | 1 | |
| HORSE CHESTNUT | ACTIVE MOIETY | 3C18L6RJAZ | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| CITRUS PARADISI SEED | INACTIVE INGREDIENT | 12F08874Y7 | 1 | |
| FRANKINCENSE OIL | INACTIVE INGREDIENT | 67ZYA5T02K | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| LAVENDER OIL | INACTIVE INGREDIENT | ZBP1YXW0H8 | 1 | |
| MYRRH OIL | INACTIVE INGREDIENT | H74221J5J4 | 1 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| SPHAGNUM SQUARROSUM PEAT | INACTIVE INGREDIENT | Z7G226H5SA | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Amber Amethyst
- SPHAGNUM SQUARROSUM PEAT
- WATER
- STEARIC ACID
- ISOPROPYL MYRISTATE
- LAVENDER OIL
- CETYL ALCOHOL
- POLYOXYL 40 STEARATE
- STEARYL ALCOHOL
- XANTHAN GUM
- SORBIC ACID
- FRANKINCENSE OIL
- MYRRH OIL
- CITRUS PARADISI SEED
- HORSE CHESTNUT
- EQUISETUM ARVENSE TOP
- AMBER
- SILICON DIOXIDE
- TEA TREE OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48951-1270 | 48951-1270-5 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SPHAGNUM SQUARROSUM PEAT | Z7G226H5SA | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| LAVENDER OIL | ZBP1YXW0H8 | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| POLYOXYL 40 STEARATE | 13A4J4NH9I | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| FRANKINCENSE OIL | 67ZYA5T02K | IACT |
| MYRRH OIL | H74221J5J4 | IACT |
| CITRUS PARADISI SEED | 12F08874Y7 | IACT |
| HORSE CHESTNUT | 3C18L6RJAZ | ACTIB |
| EQUISETUM ARVENSE TOP | 1DP6Y6B65Z | ACTIB |
| AMBER | 70J9Z0J26P | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | ACTIB |
| TEA TREE OIL | VIF565UC2G | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TOPICAL | 7 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| POLYOXYL 40 STEARATE | POLYOXYL 40 STEARATE TYPE I | 13A4J4NH9I | TABLET / ORAL | 8.48 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | AEROSOL, FOAM / TOPICAL | 8 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SOLUTION/ DROPS / OPHTHALMIC | 0.47 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| LAVENDER OIL | LAVENDER OIL | ZBP1YXW0H8 | GEL / TOPICAL | 0.1 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED / ORAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | AEROSOL, FOAM / TOPICAL | 37 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TROCHE / ORAL | 948 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | EMULSION / TOPICAL | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / AURICULAR (OTIC) | 36 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | LOTION / TOPICAL | 1140 mg | ||
| POLYOXYL 40 STEARATE | POLYOXYL 40 STEARATE TYPE I | 13A4J4NH9I | AEROSOL, FOAM / TOPICAL | 2.83 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CONCENTRATE / ORAL | 1 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | ENEMA / RECTAL | 150 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CAPSULE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TOPICAL | 29 mg | ||
| POLYOXYL 40 STEARATE | POLYOXYL 40 STEARATE TYPE I | 13A4J4NH9I | LOTION / TOPICAL | 3 %w/w | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, COATED / ORAL | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / VAGINAL | 50 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | EMULSION / OPHTHALMIC | 0.47 %w/v | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, EXTENDED RELEASE / ORAL | 244 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUPPOSITORY / VAGINAL | 8.5 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | LOTION / TOPICAL | 0.2 %w/w | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CAPSULE, EXTENDED RELEASE / ORAL | 72 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| POLYOXYL 40 STEARATE | POLYOXYL 40 STEARATE TYPE I | 13A4J4NH9I | TABLET, FILM COATED / ORAL | 2 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, ORALLY DISINTEGRATING / ORAL | 9 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| LAVENDER OIL | LAVENDER OIL | ZBP1YXW0H8 | INHALANT / NASAL | NA | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET / ORAL | 20 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CAPSULE, DELAYED RELEASE / ORAL | 59 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 28771309-0b69-d8f0-e063-6394a90a89e3 | 8f0cebad-895e-494d-9112-a0a8ab09ea44 | 2024-12-04 | Warnings | 28771309-0b69-d8f0-e063-6394a90a89e3 8f0cebad-895e-494d-9112-a0a8ab09ea44 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
