MedPath

SOVEREIGN SILVER NATURAL HEALING SKIN CARE

Approved
Approval ID

c2d1a098-419f-4b3f-9665-bed76612d5da

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 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 Code52166-025
Product Classification
G
Generic Name
ARGENTUM METALLICUM
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (3)

CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SILVERActive
Quantity: 30 [hp_X] in 1 mL
Code: 3M4G523W1G
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/28/2025

Product label

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/27/2025

Uses

FOR RELIEF OF SYMPTOMS DUE TO SKIN ERUPTIONS FROM ACNE, ECZEMA, MINOR INFECTION, RASHES, BLISTERS, SUNBURN, RAZOR BURN, MINOR NICKS & CUTS, REDNESS & MINOR INFLAMMATION

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/27/2025

Active Ingredient

ARGENTUM METALLICUM 10X, 20X, 30X

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/27/2025

Purpose

TOPICAL ANALGESIC

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 2/27/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 2/27/2025

Warnings

FOR EXTERNAL USE ONLY. ASK A DOCTOR BEFORE SE IF YOU HAVE DEEP OR PUNCTURE WOUNDS, ANIMAL BITES OR SERIOUS BURNS. KEEP OUT OF REACH OF CHILDREN. STOP AND ASK A DOCTOR IF SYMPTOMS PERSIST OR WORSEN AFTER 3 DAYS OF USE. DO NOT USE IF THE SEAL IS BROKEN.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/27/2025

Directions

GENTLY CLEAN AFFECTED AREA. APPLY A LIBERAL, CONSISTENT LAYER OF SKIN CARE GEL OVER AFFECTED AREA. REPEAT 3 TIMES PER DAY OR AS OFTEN AS NEEDED TO RELIEVE SYMPTOMS. SAFE ON SENSITIVE SKIN.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/27/2025

Inactive Ingredients

CARBOPOL, SODIUM HYDROXIDE

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

SOVEREIGN SILVER NATURAL HEALING SKIN CARE - FDA Drug Approval Details