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]

INDICATIONS AND USAGE:

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 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:

Stick: 98 mg

CONTRAINDICATIONS:

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:

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:

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:

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:

INGREDIENTS AND APPEARANCE

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) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	24.4804 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROCHLORIC ACID (UNII: QTT17582CB)	0.0588 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.0294 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12165-300-01	1 in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	04/19/1949

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. (798817599)

Establishment
Name	Address	ID/FEI	Business Operations
GF Health Products, Inc.		798817599	manufacture(12165-300)