Silicea
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2020-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:14:00
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Cell Salt; Hemorrhoids; Keloids; Migraine; Nervousness; Constipation before and during menses.
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
Silicea 15x, 10x, 200c, 30c.
OTC - PURPOSE SECTION
Cell Salt; Hemorrhoids; Keloids; Migraine; Nervousness; Constipation before and during menses.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
QUESTIONS SECTION
newtonlabs.net - Questions? 1.800.448.7256
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-6492-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6726-a426-e053-dadaa90af4c2 | Silicea 6492L |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-6492-1 | Silicea | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-6492 | SILICEA LIQUID [NEWTON LABORATORIES, INC.] | 2 | Legacy NDC, 1 package rows | 20201218_147faa40-49bf-cfd0-4f77-c9ff266f37c1.zip |
Products#
Every source-derived product name is available through these pages.
- Silicea
- ALCOHOL
- WATER
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-6492 | 55714-6492-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| b6ae6b49-fcf8-27dc-e053-2995a90a265d | 147faa40-49bf-cfd0-4f77-c9ff266f37c1 | 2020-12-17 | Warnings | b6ae6b49-fcf8-27dc-e053-2995a90a265d 147faa40-49bf-cfd0-4f77-c9ff266f37c1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
