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FDA Approval

SOVEREIGN SILVER NATURAL HEALING SKIN CARE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Natural Immunogenics Corp.dba SOVEREIGN NATURALS
DUNS: 048744085
Effective Date
May 22, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Silver(30 [hp_X] in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Natural Immunogenics Corp.dba SOVEREIGN NATURALS

048744085

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Natural Immunogenics Corp.dba SOVEREIGN NATURALS

Natural Immunogenics Corp.dba SOVEREIGN NATURALS

Natural Immunogenics Corp.dba SOVEREIGN NATURALS

048744085

Products1

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

SOVEREIGN SILVER NATURAL HEALING SKIN CARE

Product Details

NDC Product Code
52166-025
Route of Administration
TOPICAL
Effective Date
May 22, 2025
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FCClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SilverActive
Code: 3M4G523W1GClass: ACTIBQuantity: 30 [hp_X] in 1 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product label

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INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.


WARNINGS SECTION

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.


OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

ARGENTUM METALLICUM 10X, 20X, 30X

OTC - PURPOSE SECTION

Purpose

TOPICAL ANALGESIC

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


INACTIVE INGREDIENT SECTION

Inactive Ingredients

CARBOPOL, SODIUM HYDROXIDE


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