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Sovereign Silver First Aid Gel Topical Healing Homeopathic Medicine

Approved
Approval ID

b3a22f82-fc37-4426-bef2-15ae71b1b681

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 Code52166-020
Product Classification
G
Generic Name
Argentum Metallicum
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (4)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
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: 12/4/2024

Product label

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/4/2024

Uses

FIRST AID GEL TO HELP PREVENT INFECTION IN MINOR CUTS, SCRAPES, BURNS, SKIN ERUPTIONS FROM ECZEMA, RASHES, BLISTERS, SUNBURN, RAZOR BURN, MINOR NICKS, REDNESS AND MINOR INFLAMMATION.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/4/2024

Active Ingredient

ARGENTUM METALLICUM 10X, 20X, 30X HPUS

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/4/2024

Purpose

HOMEOPATHIC REMEDY FOR TOPICAL APPLICATIONS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/21/2024

Keep out of reach of children.

WARNINGS SECTION

LOINC: 34071-1Updated: 12/4/2024

Warning

FOR EXTERNAL USE ONLY. ASK A DOCTOR BEFORE USE 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: 12/4/2024

Directions

CLEAN AFFECTED AREA. APPLY A LIBERAL, CONSISTENT LAYER OF FIRST AID GEL OVER AFFECTED AREA. LEAVE WET OR BANDAGE FOR OPTIMAL RESULTS. REPEAT 3 TIMES PER DAY OR AS OFTEN AS NEEDED TO RELIEVE SYMPTOMS. SAFE ON SENSITIVE SKIN.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/4/2024

Inactive Ingredients

CARBOPOL, SILVER HYDROSOL AND SODIUM HYDROXIDE

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Sovereign Silver First Aid Gel Topical Healing Homeopathic Medicine - FDA Drug Approval Details