GRAFCO

Manufacturer
GF Health Products, Inc.
Effective date
2011-10-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-02 01:50:38

Label at a glance#

ProductGRAFCO APPLICATOR 15 CM
Active ingredientSilver Nitrate, Potassium Nitrate
Label structure11 sections

Storage and handling

STORAGE: Store in the closed package at room temperature in a dry place and protected from light. Silver nitrate will turn black upon exposure to light, however this does not affect the product’s potency or utility.

Label contents#

Full prescribing information#

COMPONENTS

Active Ingredients: Each Applicator Contains
Silver Nitrate. . . . . . . . . . . . . . . . . . . . . . . . . 75%
Potassium Nitrate. . . . . . . . . . . . . . . . . . . . . 25%

INDICATIONS & USAGE SECTION

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

INSTRUCTIONS FOR USE SECTION

DIRECTIONS: The healthcare professional moistens the applicator tip with distilled water and applies it to the affected area. The strength
of the action is controlled by the dilution with distilled water. One Grafco® Silver Nitrate applicator is generally sufficient for each application.

CONTRAINDICATIONS SECTION

CONTRAINDICATIONS: Silver salts stain tissue black due to deposition of reduced silver. The stain gradually disappears within a period
of two weeks.

USER SAFETY WARNINGS SECTION

WARNINGS: 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, consult a physician. In case of eye contact, hold eyes open and immediately flush thoroughly with water for at least 15
minutes and consult a physician.

WARNINGS SECTION

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

PRECAUTIONS SECTION

PRECAUTION: Prolonged ingestion or absorption of silver compounds (organic or inorganic) whether originating industrially or
therapeutically leads to disposition 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. The nature
of the pigment is not definitely known, it may be metallic silver or oxide. This discoloration exists throughout life but does not cause any
systematic symptoms. While small patches may be removed, this method is so tedious and painful as to be impractical for large areas.

MECHANISM OF ACTION SECTION

ACTION: Silver nitrate commonly employed as a caustic antiseptic and an astringent. Potassium nitrate has been used as a topical
antiseptic on mucous membranes. The degree of action depends upon the concentration employed and the period of time during which
the compound is allowed to act. The silver nitrate is precipitated by chloride thus washing with a solution of sodium chloride can quickly
stop the action of silver ions.

STORAGE AND HANDLING SECTION

STORAGE: Store in the closed package at room temperature in a dry place and protected from light. Silver nitrate will turn black upon
exposure to light, however this does not affect the product’s potency or utility.

USER SAFETY WARNINGS SECTION

CHEMTREC 24-HOUR EMERGENCY TELEPHONE NUMBERS:
DOMESTIC/NORTH AMERICA 800-424-9300
INTERNATIONAL 703-527-3887 (CALL COLLECT)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labeling Silver NitrateImage of the labeling Silver NitrateEnter section text here

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12165-100-01EA - Each12165-1004dfd0c3e-fde0-4008-9609-4b6d6d5aeb3212019-04-11
12165-100-03EA - Each12165-100d56d8ef5-c62c-4095-8b03-90bb229b78f112012-07-24
12165-200-03EA - Each12165-200a58721d9-a18d-46a7-982d-74ade3b28e2d12021-05-05
12165-300-01EA - Each12165-30094bdb3ec-376e-4b0a-acbf-c0140763d18612022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Potassium NitrateACTIVE INGREDIENTRU45X2JN0Z7
Silver NitrateACTIVE INGREDIENT95IT3W8JZE7
Potassium CationACTIVE MOIETY295O53K1527
Silver CationACTIVE MOIETY57N7B0K90A7

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
12165-10012165-100-03
12165-20012165-200-03
12165-30012165-300-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GRAFCO APPLICATOR 15 CMSILVER NITRATEGF Health Products, Inc.41a82a8c-9a4a-4610-a115-8d8c72a25b1e2021-01-19WarningsExact identifier
ndc (product): 12165-100
GRAFCO APPLICATOR 45 CMSILVER NITRATEGF Health Products, Inc.d7622ce1-a327-4c81-b6c0-c9e8dbd395652019-12-04WarningsExact identifier
ndc (package): 12165-300-01
ndc (product): 12165-300
ndc11 (package): 12165030001
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
4fd53ece-9c0e-4743-8736-b87bf9c3fc5b0fff668c-8b5c-4b52-a740-7a078d4136202011-10-03WarningsExact identifier
spl id: 4fd53ece-9c0e-4743-8736-b87bf9c3fc5b
spl set id: 0fff668c-8b5c-4b52-a740-7a078d413620

Reported adverse events (FAERS/openFDA)#

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