Homeopathic Trauma Formula
- Manufacturer
- Indiana Botanic Gardens | ASI Marketing Group
- Effective date
- 2011-03-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:51:13
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
I n g r e d i e n t s :
Mountain arnica.......................... 30C HPUS
Deadly nightshade................................. 30C HPUS
Calendula.................... 30C HPUS
Echinacea................ 30C HPUS
St. John's wort................. 30C HPUS
Rue.......................... 30C HPUS
Comfrey................. 30C HPUS
The letters “HPUS” indicate that the components in
this product are officially monographed in the
Homeopathic Pharmacopoeia of the United States.
OTC - PURPOSE SECTION
For the symptomatic relief of minor injuries, wounds, sprains and athletic exertion
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF
REACH OF CHILDREN.
INDICATIONS & USAGE SECTION
For the symptomatic relief of minor injuries, wounds, sprains and athletic exertion
WARNINGS SECTION
Warning: If you are taking any medications or
are pregnant or breast feeding do not use prior to
consulting a physician.
DOSAGE & ADMINISTRATION SECTION
Suggested Use: Adults and children over 12
years, take 2 tablets, dissolve under tongue or
chew 3 times daily until symptoms subside, or as directed by a health care
professional. If symptoms persist for more than 10 days consult a
health professional.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Dextrose, Magnesium
Stearate, Silica.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC# 1057804490
Homeopathic Trauma Formula
For the symptomatic relief of minor injuries, wounds, sprains and athletic exertion300 mg.
90 Tablets
USER SAFETY WARNINGS SECTION
For your protection, this container has an outer
safety seal. (Do not accept if missing or broken.)
Best if used by date on bottle. Store in a dry cool place.
Any Questions? 1-800-644-8327
website:
www.botanicchoice.com
SPL UNCLASSIFIED SECTION
FDA Establishment #: 1811575
Distributed by: Indiana Botanic Gardens, Inc.
3401 W. 37th Ave. Hobart, IN 46342
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10578-044-90 | 2021-01-22 | C162847 | 48780-1 | 960f7f55-bf3f-8e05-e053-dbdaa90a074a | Homeopathic Trauma Formula |
| 10578-044-90 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-bf3f-8e05-e053-dbdaa90a074a | Homeopathic Trauma Formula |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARNICA MONTANA | ACTIVE INGREDIENT | O80TY208ZW | 2 | |
| ATROPA BELLADONNA | ACTIVE INGREDIENT | WQZ3G9PF0H | 2 | |
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE INGREDIENT | 18E7415PXQ | 2 | |
| COMFREY ROOT | ACTIVE INGREDIENT | M9VVZ08EKQ | 2 | |
| ECHINACEA ANGUSTIFOLIA | ACTIVE INGREDIENT | VB06AV5US8 | 2 | |
| HYPERICUM PERFORATUM | ACTIVE INGREDIENT | XK4IUX8MNB | 2 | |
| RUTA GRAVEOLENS FLOWERING TOP | ACTIVE INGREDIENT | N94C2U587S | 2 | |
| ARNICA MONTANA | ACTIVE MOIETY | O80TY208ZW | 2 | |
| ATROPA BELLADONNA | ACTIVE MOIETY | WQZ3G9PF0H | 2 | |
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE MOIETY | 18E7415PXQ | 2 | |
| COMFREY ROOT | ACTIVE MOIETY | M9VVZ08EKQ | 2 | |
| ECHINACEA ANGUSTIFOLIA | ACTIVE MOIETY | VB06AV5US8 | 2 | |
| HYPERICUM PERFORATUM | ACTIVE MOIETY | XK4IUX8MNB | 2 | |
| RUTA GRAVEOLENS FLOWERING TOP | ACTIVE MOIETY | N94C2U587S | 2 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 |
Products#
Every source-derived product name is available through these pages.
- Homeopathic Trauma Formula
- Arnica montana, Belladonna, Calendula officinalis, Echinacea angustafolia, Hypericum perforatum, Ruta graveolens, Symphytum officinalis
- ARNICA MONTANA
- ATROPA BELLADONNA
- CALENDULA OFFICINALIS FLOWERING TOP
- ECHINACEA ANGUSTIFOLIA
- HYPERICUM PERFORATUM
- RUTA GRAVEOLENS FLOWERING TOP
- COMFREY ROOT
- DEXTROSE
- MAGNESIUM STEARATE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10578-044 | 10578-044-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| CALENDULA OFFICINALIS FLOWERING TOP | 18E7415PXQ | ACTIB |
| ECHINACEA ANGUSTIFOLIA | VB06AV5US8 | ACTIB |
| HYPERICUM PERFORATUM | XK4IUX8MNB | ACTIB |
| RUTA GRAVEOLENS FLOWERING TOP | N94C2U587S | ACTIB |
| COMFREY ROOT | M9VVZ08EKQ | ACTIB |
| DEXTROSE | IY9XDZ35W2 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | 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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, CHEWABLE / ORAL | 1286 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | POWDER / VAGINAL | 430 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | CONCENTRATE / ORAL | 400 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION, SOLUTION / INTRAVENOUS | 51.7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION / INTRAVENOUS | 5 %w/v | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, DELAYED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TROCHE / ORAL | 903.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | SOLUTION / INTRAVENOUS | 5.05 %w/v | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | SYRUP / ORAL | 620 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | SPRAY, METERED / NASAL | 50 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET / SUBLINGUAL | 115.78 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 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 |
|---|---|---|---|---|---|---|
| 19259540-338f-4b87-a041-3c6cc6a8c7da | fffff8c9-f224-4cdd-8ced-d6e6547b2994 | 2021-01-22 | Warnings | fffff8c9-f224-4cdd-8ced-d6e6547b2994 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
