The following Structured Product Label (SPL) was submitted to the FDA by Gf Health Products, Inc. for the product Grafco (NDC 12165-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage, contraindications, warnings and precautions, mechanism of action, storage and handling, disposal and waste handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 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 water. One Grafco silver nitrate applicator is generally sufficient for each application.
CONTRAINDICATIONS: Silver salts stain tissue black due to depositon 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 a least 15 minutes and consult a physician.
PRECAUTION: Silver nitrate is a caustic substance. Wear 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.
Prolonged ingestion or absorption of silver compounds (organic or inorganic); whether originating industrially or therapeutically, 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. 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 tedous and painful as to be impractical for large areas.
CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.
ACTION: Silver nitrate is 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 neutralize the action of silver ions.
STORAGE: Store in the closed package at room temperature in a dry place protected from light. Silver nitrate will turn black upon exposure to light, however this does not affect the product's potency or utility. Store away from vaporous chemicals.
DISPOSAL: Expired applicators may be retuned for disposal to: GF Health Products, Inc., 33 Plan Way, Bld. #2, Warwick, RI 02866, or disposed of according to applicable federal, state, and local regulations.
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