MedPath

Sovereign Silver

Approved
Approval ID

1a12bc4d-5bae-486f-9eb1-afff32b2a7a5

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Natural Immunogenics Corp.dba SOVEREIGN NATURALS

DUNS: 048744085

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Argentum Metallicum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52166-013
Product Classification
G
Generic Name
Argentum Metallicum
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (4)

SILVERActive
Quantity: 30 [hp_X] in 1 mL
Code: 3M4G523W1G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/16/2024

Product labels

image description

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/27/2020

Indications for use

Wound dressing gel for fast healing and relief of hot spots, skin irritations, rashes, bug bites, cuts, scrapes, scaling, minor wounds and paw
burns.

WARNINGS SECTION

LOINC: 34071-1Updated: 10/16/2024

Warnings: For external use only.

Ask a veterinarian before use if your pet has deep or puncture wounds, open sores, serious burns, or if symptoms persist or worsen after 3 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/16/2024

Keep out of reach of children.

Do not use if seal is broken.

Storage: Store at room temperature and out of direct sunlight.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/16/2024

Active ingredient Purpose

Argentum Metallicum Skin Protectant

10x, 20x, 30x HPUS

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/16/2024

Inactive Ingredients

Water, Silver, Carbopol and Sodium Hydroxide.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/16/2024

Directions

Clean affected area. Apply a liberal, consistent layer of First Aid Gel. Leave wet or bandage. Repeat up to 3 times per day as often as needed to
relieve symptoms.

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Sovereign Silver - FDA Drug Approval Details