The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein Inc. for the product Styptstix (NDC 0404-1000). 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, package label.principal display panel, 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 tip to the affected area. The strength of the action is controlled by the dilution with distilled water. One StyptStix 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.
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 asargyria. 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.
CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.
ACTION: Silver nitrate has been commonly used 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. Silver nitrate is precipitated by chloride ions, so washing with a solution of sodium chloride (table salt) will quickly stop the action of silver ions.
STORAGE: Store in 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.
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