Symphytum Hamamelis
- Manufacturer
- Uriel Pharmacy Inc.
- Effective date
- 2023-11-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 02:24:56
Label at a glance#
Contacts and useful links#
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: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: Symphytum (Comfrey) 2X, Calendula 3X, Hamamelis (Witch hazel) 3X, Ruta grav. (Rue) 3X, Allium cepa (Onion) 4X, Arnica 4X, Bellis (Daisy) 4X
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Distilled water, Organic cane alcohol
OTC - PURPOSE SECTION
Use: Promotes healing of broken bones.
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.
OTC - QUESTIONS SECTION
Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 shopuriel.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48951-8222-3 | Symphytum Hamamelis | 60 mL in 1 BOTTLE, DROPPER | LIQUID | 60 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48951-8222 | SYMPHYTUM HAMAMELIS LIQUID [URIEL PHARMACY INC.] | 5 | Legacy NDC, 1 package rows | 20231129_f05b5629-bfc2-465d-8733-b89caf35a7bd.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARNICA MONTANA | ACTIVE INGREDIENT | O80TY208ZW | 1 | |
| BELLIS PERENNIS | ACTIVE INGREDIENT | 2HU33I03UY | 1 | |
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE INGREDIENT | 18E7415PXQ | 1 | |
| COMFREY ROOT | ACTIVE INGREDIENT | M9VVZ08EKQ | 1 | |
| HAMAMELIS VIRGINIANA TOP | ACTIVE INGREDIENT | UDA30A2JJY | 1 | |
| ONION | ACTIVE INGREDIENT | 492225Q21H | 1 | |
| RUTA GRAVEOLENS FLOWERING TOP | ACTIVE INGREDIENT | N94C2U587S | 1 | |
| ARNICA MONTANA | ACTIVE MOIETY | O80TY208ZW | 1 | |
| BELLIS PERENNIS | ACTIVE MOIETY | 2HU33I03UY | 1 | |
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE MOIETY | 18E7415PXQ | 1 | |
| COMFREY ROOT | ACTIVE MOIETY | M9VVZ08EKQ | 1 | |
| HAMAMELIS VIRGINIANA TOP | ACTIVE MOIETY | UDA30A2JJY | 1 | |
| ONION | ACTIVE MOIETY | 492225Q21H | 1 | |
| RUTA GRAVEOLENS FLOWERING TOP | ACTIVE MOIETY | N94C2U587S | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Symphytum Hamamelis
- WATER
- ALCOHOL
- COMFREY ROOT
- CALENDULA OFFICINALIS FLOWERING TOP
- HAMAMELIS VIRGINIANA TOP
- RUTA GRAVEOLENS FLOWERING TOP
- ONION
- ARNICA MONTANA
- BELLIS PERENNIS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48951-8222 | 48951-8222-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| COMFREY ROOT | M9VVZ08EKQ | ACTIB |
| CALENDULA OFFICINALIS FLOWERING TOP | 18E7415PXQ | ACTIB |
| HAMAMELIS VIRGINIANA TOP | UDA30A2JJY | ACTIB |
| RUTA GRAVEOLENS FLOWERING TOP | N94C2U587S | ACTIB |
| ONION | 492225Q21H | ACTIB |
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| BELLIS PERENNIS | 2HU33I03UY | ACTIB |
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 |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 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 |
|---|---|---|---|---|---|---|
| 0b3aad69-9803-fa0a-e063-6294a90a06bf | f05b5629-bfc2-465d-8733-b89caf35a7bd | 2023-11-28 | Warnings | 0b3aad69-9803-fa0a-e063-6294a90a06bf f05b5629-bfc2-465d-8733-b89caf35a7bd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
