Ear Care
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2020-11-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:05:35
Label at a glance#
ProductEar Care
Active ingredientINFLUENZA A VIRUS, TELLURIUM, APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, CAPSICUM, CAUSTICUM, CINCHONA OFFICINALIS BARK, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURY, DAPHNE MEZEREUM BARK, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA VULGARIS, SILICON DIOXIDE, VERBASCUM THAPSUS, ECHINACEA, UNSPECIFIED, GOLDENSEAL, INFLUENZA B VIRUS
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as pain, fever, inflammation, redness, congestion, itching and pressure.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purfied water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Hydrastis 6x, Apis mel. 15x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Capsicum 15x, Causticum 15x, Cinchona 15x, Conium 15x, Dulcamara 15x, Ferrum phos. 15x, Hepar sulph. calc. 15x, Kali sulph. 15x, Lycopodium 15x, Merc. viv. 15x, Mezereum 15x, Phos. 15x, Plantago 15x, Pulsatilla 15x, Silicea 15x, Verbascum 15x, Influenzinum 30x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as pain, fever, inflammation, redness, congestion, itching and pressure.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose (lactose-free) pellets.
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
Keep out of reach of children.
PACKAGE LABEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-2425-1 | 2023-11-27 | C162847 | 48780-1 | f386c649-e025-0266-e053-dadaa90a7c1a | Ear 2425P |
| 55714-2425-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-e025-0266-e053-dadaa90a7c1a | Ear 2425P |
Products#
Every source-derived product name is available through these pages.
- Ear Care
- Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis
- SUCROSE
- INFLUENZA A VIRUS
- TELLURIUM
- APIS MELLIFERA
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- ATROPA BELLADONNA
- BRYONIA ALBA ROOT
- CAPSICUM
- CAUSTICUM
- CINCHONA OFFICINALIS BARK
- CONIUM MACULATUM FLOWERING TOP
- SOLANUM DULCAMARA TOP
- FERROSOFERRIC PHOSPHATE
- CALCIUM SULFIDE
- POTASSIUM SULFATE
- SULFATE ION
- LYCOPODIUM CLAVATUM SPORE
- MERCURY
- DAPHNE MEZEREUM BARK
- PHOSPHORUS
- PLANTAGO MAJOR
- PULSATILLA VULGARIS
- SILICON DIOXIDE
- VERBASCUM THAPSUS
- ECHINACEA, UNSPECIFIED
- GOLDENSEAL
- INFLUENZA B VIRUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2425 | 55714-2425-1 |
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 |
|---|---|---|---|---|---|---|
| 0b280af0-2c3e-1db7-e063-6394a90a6852 | 91ad71fa-8b9d-e2fa-e053-2995a90af990 | 2023-11-27 | Warnings | 91ad71fa-8b9d-e2fa-e053-2995a90af990 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.