Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 4 days, consult your health care professional. Consult a physician for use in children under 12 years of age.
(in each drop): 12.48% of Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Ferrum Phosphoricum 12X, Hydrastis Canadensis 6X, Mercurius Solubilis 12X, Phytolacca Decandra 6X, Pulsatilla (Pratensis) 12X; 0.10% of Baptisia Tinctoria 3X, Echinacea Angustifolia 3X.
May temporarily relieve mild ear disorders with soreness, sticking pain in ear, and minor swelling of the ear with redness.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 4 days, consult your health care professional. Consult a physician for use in children under 12 years of age.
May temporarily relieve mild ear disorders with soreness, sticking pain in ear, and minor swelling of the ear with redness.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Demineralized water, 20% Ethanol.
Dist. by Energique, Inc.
201 Apple Blvd
Woodbine, IA 51579 800.869.8078
ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
OTOTONE
1 fl. oz. (30 ml)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 44911-0467-1 | 2024-10-29 | C162847 | 48780-1 | 1030e365-1887-111a-e063-dadaa90a10e2 | DRUG FACTS: |
| 44911-0467-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1887-111a-e063-dadaa90a10e2 | DRUG FACTS: |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44911-0467-1 | Ototone | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44911-0467 | OTOTONE (BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, FERRUM PHOSPHORICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS)) LIQUID [ENERGIQUE, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241031_c34e0abf-02d8-4dee-a89b-3f61ab593dc3.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 44911-0467 | 44911-0467-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BAPTISIA TINCTORIA ROOT | 5EF0HWI5WU | ACTIB |
| ECHINACEA ANGUSTIFOLIA WHOLE | VB06AV5US8 | ACTIB |
| GOLDENSEAL | ZW3Z11D0JV | ACTIB |
| PHYTOLACCA AMERICANA ROOT | 11E6VI8VEG | ACTIB |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 2E32821G6I | ACTIB |
| MATRICARIA CHAMOMILLA WHOLE | G0R4UBI2ZZ | ACTIB |
| FERROSOFERRIC PHOSPHATE | 91GQH8I5F7 | ACTIB |
| MERCURIUS SOLUBILIS | 324Y4038G2 | ACTIB |
| PULSATILLA PRATENSIS WHOLE | 8E272251DI | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
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 |
|---|---|---|---|---|---|---|
| Ototone | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, FERRUM PHOSPHORICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS) | Energique, Inc. | c34e0abf-02d8-4dee-a89b-3f61ab593dc3 | 2024-10-29 | Warnings | 44911-0467-1 44911-0467 44911046701 16dcd12c-ba0d-4cb5-afec-6de76a1bbfae c34e0abf-02d8-4dee-a89b-3f61ab593dc3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.