Label: STYPTSTIX- silver nitrate applicator stick
- NDC Code(s): 0404-1000-01, 0404-1000-02, 0404-1000-03
- Packager: Henry Schein 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.
Updated December 4, 2019
If you are a consumer or patient please visit this version.
- INDICATIONS AND USAGE:
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:
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
• Wear chemical resistant gloves while using this product. Wear other appropriate personal protective equipment as
• 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.
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 vaporous
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
silver nitrate applicator stick
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-1000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 38.21 mg POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 12.74 mg Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID (UNII: QTT17582CB) 0.042 mg SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.021 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0404-1000-01 16 in 1 CASE 06/01/2014 1 NDC:0404-1000-02 12 in 1 BOX 1 NDC:0404-1000-03 100 in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 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)