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.

Drug Label Information

Updated December 4, 2019

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  • 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 vaporous
    chemicals.

  • DISPOSAL:

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

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    STYPTSTIX 
    silver nitrate applicator stick
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-1000
    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) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE12.74 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB) 0.042 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.021 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-1000-0116 in 1 CASE06/01/2014
    1NDC:0404-1000-0212 in 1 BOX
    1NDC:0404-1000-03100 in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2014
    Labeler - Henry Schein Inc. (012430880)