Ear Wax Build-Up
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2025-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:31:48
Label at a glance#
ProductEar Wax Build-Up
Active ingredientMICRURUS CORALLINUS VENOM, ALUMINUM OXIDE, ACTIVATED CHARCOAL, CAUSTICUM, CONIUM MACULATUM FLOWERING TOP, GRAPHITE, POTASSIUM DICHROMATE, POTASSIUM CHLORIDE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, LIQUID PETROLEUM, PULSATILLA VULGARIS, SCHOENOCAULON OFFICINALE SEED, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, VERBASCUM THAPSUS, VIOLA ODORATA
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Equal parats of Alumina 15x, Carbo veg. 15x, Causticum 15x, Conium 15x, Graphites 15x, Kali bic. 15x, Kali mur. 15x, Lachesis 15x, Lycopodium 15x, Petroleum 15x, Pulsatilla 15x, Sabadilla 15x, Sepia 15x, Silicea 15x, Spongia 15x, Verbascum 15x, Viola odorata 15x, Elaps 30x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: 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 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
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2428-0 | Ear Wax Build-Up | 15 mL in 1 BOTTLE, GLASS | LIQUID | 15 | 3 | |
| 55714-2428-1 | Ear Wax Build-Up | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 3 | |
| 55714-2428-2 | Ear Wax Build-Up | 50 mL in 1 BOTTLE, GLASS | LIQUID | 50 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2428 | EAR WAX BUILD-UP (ELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATA) LIQUID [NEWTON LABORATORIES, INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20250209_9302b838-6003-ba6a-e053-2995a90aedd3.zip |
Products#
Every source-derived product name is available through these pages.
- Ear Wax Build-Up
- Elaps corallinus, Alumina, Carbo veg., Causticum, Conium, Graphites, Kali bic.,Kali mur., Lachesis, Lycopodium, Petroleum, Pulsatilla, Sabadilla, Sepia, Silicea, Spongia, Verbascum, Viola odorata
- ALCOHOL
- MICRURUS CORALLINUS VENOM
- ALUMINUM OXIDE
- ACTIVATED CHARCOAL
- CAUSTICUM
- CONIUM MACULATUM FLOWERING TOP
- GRAPHITE
- POTASSIUM DICHROMATE
- DICHROMATE ION
- POTASSIUM CHLORIDE
- POTASSIUM CATION
- LACHESIS MUTA VENOM
- LYCOPODIUM CLAVATUM SPORE
- LIQUID PETROLEUM
- PULSATILLA VULGARIS
- SCHOENOCAULON OFFICINALE SEED
- SEPIA OFFICINALIS JUICE
- SILICON DIOXIDE
- SPONGIA OFFICINALIS SKELETON, ROASTED
- VERBASCUM THAPSUS
- VIOLA ODORATA
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2428 | 55714-2428-1, 55714-2428-2, 55714-2428-0 |
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 Wax Build-Up | ELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATA | Newton Laboratories, Inc. | 9302b838-6003-ba6a-e053-2995a90aedd3 | 2025-02-06 | Warnings | 55714-2428-2 55714-2428-1 55714-2428-0 55714-2428 55714242800 55714242801 55714242802 2d819832-46da-b357-e063-6394a90abd0f 9302b838-6003-ba6a-e053-2995a90aedd3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.