Grafco Applicator

Pronunciation

Generic Name: silver nitrate
Dosage Form: topical stick

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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

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

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.

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

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.

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: 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.

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

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GRAFCO  APPLICATOR 15 CM
silver nitrate stick
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:12165-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Silver Nitrate (Silver Cation) Silver Nitrate 38.21 mg
Potassium Nitrate (Potassium Cation) Potassium Nitrate 12.74 mg
Packaging
# Item Code Package Description
1 NDC:12165-100-03 12 TUBE (TUBE) in 1 BOX
1 100 STICK (APPLICATOR) 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 LABEL Item Code (Source) NDC:12165-200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Silver Nitrate (Silver Cation) Silver Nitrate 52.451 mg
Potassium Nitrate (Potassium Cation) Potassium Nitrate 17.486 mg
Packaging
# Item Code Package Description
1 NDC:12165-200-03 100 STICK (APPLICATOR) 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 LABEL Item Code (Source) NDC:12165-300
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Silver Nitrate (Silver Cation) Silver Nitrate 73.4314 mg
Potassium Nitrate (Potassium Cation) Potassium Nitrate 24.4804 mg
Packaging
# Item Code Package Description
1 NDC:12165-300-01 1 STICK (APPLICATOR) 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 Operations
GF Health Products, Inc. 798817599 manufacture
Revised: 10/2011
 
GF Health Products, Inc.



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