GRAFCO APPLICATOR 15 CM- silver nitrate stick GRAFCO APPLICATOR 30 CM- silver nitrate stick GRAFCO APPLICATOR 45 CM- silver nitrate stick

GRAFCO by

Drug Labeling and Warnings

GRAFCO by is a Prescription medication manufactured, distributed, or labeled by GF Health Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPONENTS

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

INDICATIONS & USAGE

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

INSTRUCTIONS FOR USE

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

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

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

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

PRECAUTIONS

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

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

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

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

GRAFCO  APPLICATOR 15 CM
silver nitrate stick

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 12165-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A)	Silver Nitrate	38.21 mg
Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152)	Potassium Nitrate	12.74 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12165-100-03	12 in 1 BOX
1		100 in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/19/1949

GRAFCO  APPLICATOR 30 CM
silver nitrate stick

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 12165-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A)	Silver Nitrate	52.451 mg
Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152)	Potassium Nitrate	17.486 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12165-200-03	100 in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/19/1949

GRAFCO  APPLICATOR 45 CM
silver nitrate stick

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 12165-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A)	Silver Nitrate	73.4314 mg
Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152)	Potassium Nitrate	24.4804 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12165-300-01	1 in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/19/1949

Labeler - GF Health Products, Inc. (132016168)

Registrant - GF Health Products, Inc. (132016168)

Establishment
Name	Address	ID/FEI	Business Operations
GF Health Products, Inc.		798817599	manufacture