STYPTSTIX

STYPTSTIX- silver nitrate and potassium nitrate stick
Henry Schein Inc.

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.

INDICATIONS AND USAGE:

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: 50 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 vaporouschemicals.

DISPOSAL:

Expired or unused applicators may be disposed of according to applicable federal, state and local regulations.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

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STYPTSTIX silver nitrate applicator stick
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-1000
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 (NITRATE ION) POTASSIUM NITRATE 12.74 mg
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID 0.042 mg
SODIUM CHLORIDE 0.021 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-1000-01 16 BOX in 1 CASE contains a BOX (0404-1000-02)
1 NDC:0404-1000-02 12 TUBE in 1 BOX This package is contained within the CASE (0404-1000-01) and contains a TUBE (0404-1000-03)
1 NDC:0404-1000-03 100 STICK in 1 TUBE This package is contained within a BOX (0404-1000-02) and a CASE (0404-1000-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2014
Labeler — Henry Schein Inc. (012430880)

Revised: 12/2019 Henry Schein Inc.

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