Traumatone
- Manufacturer
- Apotheca Company
- Effective date
- 2022-04-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:04:11
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: Calendula officinalis 3X, Symphytum officinale 3X, Staphysagria 12X, Rhus toxicodendron 12X, Ruta graveolens 12X, Bellis perennis 12X, Ledum palustre 12X, Hypericum perforatum 12X, Strontium carbonicum 12X, Phosphorus 123X, Arnica montana 12X.
OTC - PURPOSE SECTION
INDICATIONS: For temporary relief of soreness after exertion, pain and swelling in joints after strain or sprain, bruised joints and tendons.
WARNINGS SECTION
WARNINGS: If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
SUGGESTED USE: Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.
INDICATIONS & USAGE SECTION
INDICATIONS: For temporary relief of soreness after exertion, pain and swelling in joints after strain or sprain, bruised joints and tendons.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol.
OTC - QUESTIONS SECTION
Dist. by Energique, Inc.
201 Apple Blve.
Woodbine, IA 51579
800-869-8078
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ENERGIQUE
TRAUMATONE
Homeopathic Remedy
1 fl. oz. (30 ml)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57520-0563-1 | 2022-04-06 | C162847 | 48780-1 | 9d75b9d0-3166-f424-e053-dadaa90a57ce | Traumatone |
| 57520-0563-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3166-f424-e053-dadaa90a57ce | Traumatone |
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 | |
| DELPHINIUM STAPHISAGRIA SEED | ACTIVE INGREDIENT | 00543AP1JV | 1 | |
| HYPERICUM PERFORATUM | ACTIVE INGREDIENT | XK4IUX8MNB | 1 | |
| LEDUM PALUSTRE TWIG | ACTIVE INGREDIENT | 877L01IZ0P | 1 | |
| PHOSPHORUS | ACTIVE INGREDIENT | 27YLU75U4W | 1 | |
| RUTA GRAVEOLENS FLOWERING TOP | ACTIVE INGREDIENT | N94C2U587S | 1 | |
| STRONTIUM CARBONATE | ACTIVE INGREDIENT | 41YPU4MMCA | 1 | |
| TOXICODENDRON PUBESCENS LEAF | ACTIVE INGREDIENT | 6IO182RP7A | 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 | |
| DELPHINIUM STAPHISAGRIA SEED | ACTIVE MOIETY | 00543AP1JV | 1 | |
| HYPERICUM PERFORATUM | ACTIVE MOIETY | XK4IUX8MNB | 1 | |
| LEDUM PALUSTRE TWIG | ACTIVE MOIETY | 877L01IZ0P | 1 | |
| PHOSPHORUS | ACTIVE MOIETY | 27YLU75U4W | 1 | |
| RUTA GRAVEOLENS FLOWERING TOP | ACTIVE MOIETY | N94C2U587S | 1 | |
| STRONTIUM CATION | ACTIVE MOIETY | 37077S2C93 | 1 | |
| TOXICODENDRON PUBESCENS LEAF | ACTIVE MOIETY | 6IO182RP7A | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Traumatone
- Calendula officinalis, Symphytum officinale, Staphysagria, Rhus Toxicodendron, Ruta Graveolens, Bellis perennis,
- CALENDULA OFFICINALIS FLOWERING TOP
- COMFREY ROOT
- DELPHINIUM STAPHISAGRIA SEED
- TOXICODENDRON PUBESCENS LEAF
- RUTA GRAVEOLENS FLOWERING TOP
- BELLIS PERENNIS
- LEDUM PALUSTRE TWIG
- HYPERICUM PERFORATUM
- STRONTIUM CARBONATE
- STRONTIUM CATION
- PHOSPHORUS
- ARNICA MONTANA
- WATER
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57520-0563 | 57520-0563-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CALENDULA OFFICINALIS FLOWERING TOP | 18E7415PXQ | ACTIB |
| COMFREY ROOT | M9VVZ08EKQ | ACTIB |
| DELPHINIUM STAPHISAGRIA SEED | 00543AP1JV | ACTIB |
| TOXICODENDRON PUBESCENS LEAF | 6IO182RP7A | ACTIB |
| RUTA GRAVEOLENS FLOWERING TOP | N94C2U587S | ACTIB |
| BELLIS PERENNIS | 2HU33I03UY | ACTIB |
| LEDUM PALUSTRE TWIG | 877L01IZ0P | ACTIB |
| HYPERICUM PERFORATUM | XK4IUX8MNB | ACTIB |
| STRONTIUM CARBONATE | 41YPU4MMCA | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | 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 |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w |
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 |
|---|---|---|---|---|---|---|
| dd845fdf-efdc-44da-a684-8d6c96f2e8e3 | 7028d54a-4d61-4408-bcc2-a1cc18f135c7 | 2022-04-06 | Warnings | dd845fdf-efdc-44da-a684-8d6c96f2e8e3 7028d54a-4d61-4408-bcc2-a1cc18f135c7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
