Indications and uses
Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.
Ear Care
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2022-03-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:17:11
Label at a glance#
ProductEar Care
Active ingredientINFLUENZA B VIRUS, ECHINACEA, UNSPECIFIED, FERROSOFERRIC PHOSPHATE, APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, CAPSICUM, CAUSTICUM, CINCHONA OFFICINALIS BARK, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURY, DAPHNE MEZEREUM BARK, PHOSPHORUS, SILICON DIOXIDE, PLANTAGO MAJOR, ANEMONE PULSATILLA, TELLURIUM, VERBASCUM THAPSUS, INFLUENZA A VIRUS, CALCIUM SULFIDE, GOLDENSEAL
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS AND USAGE SECTION
Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.
DOSAGE & ADMINISTRATION SECTION
Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) one to four times daily or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Apis mellifica 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Capsicum annuum 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Dulcamara 15x, Ferrum phosphoricum 15x, Hepar sulphuris calcareum 15x, Kali sulphuricum 15x, Lycopodium clavatum 15x, Mercurius vivus 15x, Mezereum 15x, Phosphorus 15x, Plantago major 15x, Pulsatilla 15x, Silicea 15x, Tellurium metallicum 16x, Verbascum thapsus 15x, Influenzinum 30x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.
INACTIVE INGREDIENT SECTION
USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%
QUESTIONS SECTION
newtonlabs.net – Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
WARNINGS SECTION
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
WARNINGS: Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-1537-1 | Ear Care | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-1537 | EAR CARE (ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM) LIQUID [NEWTON LABORATORIES, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20220319_da717cf0-54af-c4e2-e053-2995a90ac97c.zip |
Products#
Every source-derived product name is available through these pages.
- Ear Care
- Echinacea, Hydrastis canadensis, Apis mellifica, Arsenicum album, Belladonna, Bryonia, Capsicum annuum, Causticum, Cinchona officinalis, Conium maculatum, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali sulphuricum, Lycopodium clavatum, Mercurius vivus, Mezereum, Phosphorus, Plantago major, Pulsatilla, Silicea, Verbascum thapsus, Tellurium metallicum, Influenzinum
- INFLUENZA B VIRUS
- ECHINACEA, UNSPECIFIED
- FERROSOFERRIC PHOSPHATE
- APIS MELLIFERA
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- ATROPA BELLADONNA
- BRYONIA ALBA ROOT
- CAPSICUM
- CAUSTICUM
- CINCHONA OFFICINALIS BARK
- CONIUM MACULATUM FLOWERING TOP
- SOLANUM DULCAMARA TOP
- WATER
- POTASSIUM SULFATE
- POTASSIUM CATION
- LYCOPODIUM CLAVATUM SPORE
- MERCURY
- DAPHNE MEZEREUM BARK
- PHOSPHORUS
- ALCOHOL
- SILICON DIOXIDE
- PLANTAGO MAJOR
- ANEMONE PULSATILLA
- TELLURIUM
- VERBASCUM THAPSUS
- INFLUENZA A VIRUS
- CALCIUM SULFIDE
- GOLDENSEAL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-1537 | 55714-1537-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Ear Care | ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM | Newton Laboratories, Inc. | da717cf0-54af-c4e2-e053-2995a90ac97c | 2022-03-17 | Warnings | 55714-1537-1 55714-1537 55714153701 da717cf0-54b0-c4e2-e053-2995a90ac97c da717cf0-54af-c4e2-e053-2995a90ac97c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.