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#

ProductAmber Amethyst
Active ingredientHORSE CHESTNUT, EQUISETUM ARVENSE TOP, AMBER, 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: 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

Amber Amethyst CreamAmber Amethyst Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1270-5Amber Amethyst60 g in 1 TUBECREAM604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1270AMBER AMETHYST CREAM [URIEL PHARMACY INC.]4Legacy NDC, 1 package rows20241207_8f0cebad-895e-494d-9112-a0a8ab09ea44.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMBERACTIVE INGREDIENT70J9Z0J26P1
COLLOIDAL SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
EQUISETUM ARVENSE TOPACTIVE INGREDIENT1DP6Y6B65Z1
HORSE CHESTNUTACTIVE INGREDIENT3C18L6RJAZ1
AMBERACTIVE MOIETY70J9Z0J26P1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
EQUISETUM ARVENSE TOPACTIVE MOIETY1DP6Y6B65Z1
HORSE CHESTNUTACTIVE MOIETY3C18L6RJAZ1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y71
FRANKINCENSE OILINACTIVE INGREDIENT67ZYA5T02K1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
MYRRH OILINACTIVE INGREDIENTH74221J5J41
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9I1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SPHAGNUM SQUARROSUM PEATINACTIVE INGREDIENTZ7G226H5SA1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-127048951-1270-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 3 · 139 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL / TOPICAL9.3 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TOPICAL7 mgExact identifier — unii candidate
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9ITABLET / ORAL8.48 mgExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION/ DROPS / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YAEROSOL, FOAM / TOPICAL37 mgExact identifier — unii candidate
12 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOIL / AURICULAR (OTIC)36 mgExact identifier — unii candidate
18 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YLOTION / TOPICAL1140 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9IAEROSOL, FOAM / TOPICAL2.83 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
12 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9ILOTION / TOPICAL3 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / VAGINAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YTABLET, EXTENDED RELEASE / ORAL244 mgExact identifier — unii candidate
12 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YSUPPOSITORY / VAGINAL8.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4LOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCAPSULE, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9ITABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
13 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii candidate
19 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YTABLET / ORAL20 mgExact identifier — unii candidate
12 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates

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
28771309-0b69-d8f0-e063-6394a90a89e38f0cebad-895e-494d-9112-a0a8ab09ea442024-12-04WarningsExact identifier
spl id: 28771309-0b69-d8f0-e063-6394a90a89e3
spl set id: 8f0cebad-895e-494d-9112-a0a8ab09ea44

Reported adverse events (FAERS/openFDA)#

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