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

  • NDC Code(s): 12165-100-03, 12165-200-03, 12165-300-01
  • Packager: GF Health Products, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated October 3, 2011

If you are a consumer or patient please visit this version.

  • 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

    Image of the labeling Silver NitrateEnter section text here

  • INGREDIENTS AND APPEARANCE
    GRAFCO  APPLICATOR 15 CM
    silver nitrate stick
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12165-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate38.21 mg
    Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152) Potassium Nitrate12.74 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12165-100-0312 in 1 BOX
    1100 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/19/1949
    GRAFCO  APPLICATOR 30 CM
    silver nitrate stick
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12165-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate52.451 mg
    Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152) Potassium Nitrate17.486 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12165-200-03100 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/19/1949
    GRAFCO  APPLICATOR 45 CM
    silver nitrate stick
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12165-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate73.4314 mg
    Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152) Potassium Nitrate24.4804 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12165-300-011 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/19/1949
    Labeler - GF Health Products, Inc. (132016168)
    Registrant - GF Health Products, Inc. (132016168)
    Establishment
    NameAddressID/FEIBusiness Operations
    GF Health Products, Inc.798817599manufacture