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FDA Approval

Argentyn 23

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.

Argentyn 23

Product Details

NDC Product Code
52166-001
Route of Administration
TOPICAL
Effective Date
May 22, 2025
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31Class: 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

52166-001-03 5ML

image description


INDICATIONS & USAGE SECTION

Indications for Use: For relief of these symptoms

due to minor wounds and burns, bruises, ulcerations,

sunburn, razor burn, scrapes, rashes, blisters, bug bites,

and skin eruptions form acne, eczema, or minor infection:

burning

stinging

itching

redness

stiffness

minor pain

minor inflammation

DOSAGE & ADMINISTRATION SECTION

Directions. Clean affected area. Apply a liberal,

consistent layer of First Aid Gel. Leave wet or bandage for optimal results. Repeat 3 times

per day or as often as needed to relieve symptoms


WARNINGS SECTION

Warnings. For external use only.

Ask a doctor before use of you have deep or puncture wounds,

animal bites or serious burns.

Adult supervision required.


OTC - ACTIVE INGREDIENT SECTION

Ingredients: ACTIVE:

Argentum Mettalicum 10x, 20x and 30x HPUS

OTC - PURPOSE SECTION

First Aid Gel

Homeopathic Medicine

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children


INACTIVE INGREDIENT SECTION

Inactive: Silver Hydrosol, carbopol

and Sodium hydroxide


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