GRAFCO

Manufacturer
GF Health Products, Inc.
Effective date
2019-12-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:31:15

Label at a glance#

ProductGRAFCO APPLICATOR 30 CM
Active ingredientSILVER NITRATE, POTASSIUM NITRATE
Label structure8 sections

Indications and uses

INDICATIONS:  For cauterization of skin or mucous membrane and for removing warts and granulated tissue.

Dosage and administration

Moisten the applicator tip with distilled, deionized or purified water and apply the silver nitrate to the affected area by holding, rubbing, or rotating the tip along the affected tissue. The strength of the action is controlled by the dilution with distilled, deionized or purified water. One silver nitrate applicator is generally sufficient for each application. The action of the silver nitrate can be stopped by...

Storage and handling

Store in the closed package at room temperature in a dry place protected from light. Silver nitrate will oxidize and turn dark brown upon exposure to light, however this does not affect the product’s potency or utility. Exposure to moisture can cause the tip to break or loosen from the applicator. Store away from vaporous chemicals.  

Label contents#

Full prescribing information#

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

INDICATIONS:  For cauterization of skin or mucous membrane and for removing warts and granulated tissue.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Moisten the applicator tip with distilled, deionized or purified water and apply the silver nitrate to the affected area by holding, rubbing, or rotating the tip along the affected tissue. The strength of the action is controlled by the dilution with distilled, deionized or purified water. One silver nitrate applicator is generally sufficient for each application. The action of the silver nitrate can be stopped by washing the area with saline solution (0.9% sodium chloride). Using saline solution to wet the applicator tips, or residual saline from wound flushing/washing will interfere with the action of silver nitrate resulting in cauterization failure. Only use distilled, deionized or purified water to wet applicator tips. Blot dry wounds that have been flushed/washed with saline prior to applying silver nitrate.

DOSAGE FORMS AND STRENGTHS:

DOSAGE FORMS & STRENGTHS SECTION

Stick: 70 mg

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

Silver salts stain tissue black due to deposition of reduced silver. The stain gradually disappears within a period of two weeks. Prolonged ingestion or absorption of silver compounds leads to deposition of silver in connective tissues, producing a slate-blue discoloration of the skin known as argyria. This discoloration may also appear on mucous membranes such as the margins of gums. The sclera of the eye is also stained.

WARNINGS AND PRECAUTIONS:

WARNINGS AND PRECAUTIONS SECTION

WARNING: KEEP OUT OF REACH OF CHILDREN. The active ingredients are poisonous and may be fatal when ingested in sufficient doses. The symptoms include toxic gastroenteritis, which may lead to coma, convulsion, paralysis and profound alteration of respiration. If poisoning occurs, immediately consult a physician.
WARNING: DO NOT USE ON THE EYES. In case of eye contact, hold eyes open and immediately flush thoroughly with water for at least 15 minutes and consult a physician.
CAUTION: SILVER NITRATE IS A CAUSTIC SUBSTANCE. Chemical burns may result from inappropriate use of product.
• Wear chemical resistant gloves while using this product. Wear other appropriate personal protective equipment as needed.
• Take care to confine the silver nitrate to the area being treated by using an appropriate physical or chemical barrier to prevent staining or burning of untreated tissue.
• Skin contact time with applicators should be minimal when used on thin delicate skin or neonates.
• Avoid prolonged contact with skin or other surfaces since staining may occur.
CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

STORAGE:

STORAGE AND HANDLING SECTION

Store in the closed package at room temperature in a dry place protected from light. Silver nitrate will oxidize and turn dark brown upon exposure to light, however this does not affect the product’s potency or utility. Exposure to moisture can cause the tip to break or loosen from the applicator. Store away from vaporous chemicals.  

DISPOSAL:

DISPOSAL AND WASTE HANDLING

Expired or unused applicators may be returned for disposal to: GF Health Products, Inc., 33 Plan Way, Bldg. # 2, Warwick, RI 02886, or disposed of according to applicable federal, state and local regulations.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1117536potassium nitrate 25 % / silver nitrate 75 % Medicated PadPSN3
1117536potassium nitrate 250 MG/ML / silver nitrate 750 MG/ML Medicated PadSCD3
1117536K+ nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated PadSY3
1117536Pot nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated PadSY3
1117536potassium nitrate 25 % / silver nitrate 75 % Topical SpongeSY3
1117536potassium nitrate 25 % / silver nitrate 75 % Topical StickSY3
1117536potassium nitrate 25 % / silver nitrate 75 % Topical SwabSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12165-200-03GRAFCOAPPLICATOR 30 CM100 in 1 TUBESTICK1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12165-200GRAFCO APPLICATOR 30 CM (SILVER NITRATE) STICK [GF HEALTH PRODUCTS, INC.]3Current NDC, Legacy NDC, 1 package rows20200104_8c4f8326-af2e-4658-a247-e29cd1c0fd68.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12165-200-03EA - Each12165-200a58721d9-a18d-46a7-982d-74ade3b28e2d12021-05-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12165-20012165-200-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GRAFCO APPLICATOR 30 CMSILVER NITRATEGF Health Products, Inc.8c4f8326-af2e-4658-a247-e29cd1c0fd682019-12-04WarningsExact identifier
ndc (package): 12165-200-03
ndc (product): 12165-200
ndc11 (package): 12165020003
spl id: 91d77ae9-6d0f-4f0e-a7b2-b6a270ce90a4
spl set id: 8c4f8326-af2e-4658-a247-e29cd1c0fd68

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.