SILICEA

Manufacturer: SEVENE USA
Effective date: 2025-02-11
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 02:32:06

Label at a glance#

ProductSILICEA 6X

Active ingredientSILICON DIOXIDE

Label structure11 sections

Indications and uses

Healthy skin, hair and nails**.

Dosage and administration

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

SILICEA 6X**.

**C, K, CK & X are homeopathic dilutions.

TRADITIONALLY USE TO HELP PROMOTE:

OTC - PURPOSE SECTION

Healthy skin, hair and nails*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

USES:

INDICATIONS & USAGE SECTION

Healthy skin, hair and nails**.

WARNINGS:

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional prior to use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
In case of overdose, get medical help.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Store at room temperature.
Do not use if tamper-evidence seal is broken.
Organic verified by Alpes Contrôle 2021/A03M216K/1.

INACTIVE INGREDIENT:

INACTIVE INGREDIENT SECTION

Organic Sucrose.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Email us at: info@ollois.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Silicea_6X_80ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76472-4099-1	2025-02-11	C162847	48780-1	2cef2736-6de7-d83d-e063-dadaa90ab31f	Sevene USA (as PLD) - SILICEA 6X (76472-4099)
76472-4099-1	2025-01-30	C162847	48780-1	2cef2736-6de7-d83d-e063-dadaa90ab31f	Sevene USA (as PLD) - SILICEA 6X (76472-4099)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76472-4099-1	SILICEA6X	80 in 1 CYLINDER	PELLET	80		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76472-4099	SILICEA 6X (SILICEA) PELLET [SEVENE USA]	4	Current NDC, 1 package rows	20250213_ff0e0009-8bbe-e0eb-e053-6294a90afa82.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

SILICEA 6X
SILICEA
SUCROSE
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76472-4099	76472-4099-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SUCROSE	C151H8M554	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	ACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SILICEA 6X	SILICEA	SEVENE USA	ff0e0009-8bbe-e0eb-e053-6294a90afa82	2025-02-11	Warnings	Exact identifier ndc (package): 76472-4099-1 ndc (product): 76472-4099 ndc11 (package): 76472409901 spl id: 2ddc6c12-b1c1-0ab9-e063-6394a90a6fd3 spl set id: ff0e0009-8bbe-e0eb-e053-6294a90afa82

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.