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NDC 00404-1000-01 STYPTSTIX 12.74; 38.21 mg/1; mg/1 Details
STYPTSTIX 12.74; 38.21 mg/1; mg/1
STYPTSTIX is a TOPICAL STICK in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Henry Schein Inc.. The primary component is POTASSIUM NITRATE; SILVER NITRATE.
Product Information
NDC | 00404-1000 |
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Product ID | 0404-1000_c8af694a-3717-4b64-935a-3dd762bb5579 |
Associated GPIs | |
GCN Sequence Number | 062055 |
GCN Sequence Number Description | silver nitrate applicator STICK (EA) 75 %-25 % TOPICAL |
HIC3 | L5A |
HIC3 Description | KERATOLYTICS |
GCN | 97839 |
HICL Sequence Number | 017855 |
HICL Sequence Number Description | SILVER NITRATE/POTASSIUM NITRATE |
Brand/Generic | Generic |
Proprietary Name | STYPTSTIX |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | SILVER NITRATE APPLICATOR |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | STICK |
Route | TOPICAL |
Active Ingredient Strength | 12.74; 38.21 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | POTASSIUM NITRATE; SILVER NITRATE |
Labeler Name | Henry Schein Inc. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | UNAPPROVED DRUG OTHER |
Application Number | n/a |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 00404-1000-01 (00404100001)
NDC Package Code | 0404-1000-01 |
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Billing NDC | 00404100001 |
Package | 16 BOX in 1 CASE (0404-1000-01) / 12 TUBE in 1 BOX (0404-1000-02) / 100 STICK in 1 TUBE (0404-1000-03) |
Marketing Start Date | 2014-06-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b7634e27-3c75-4e56-ab42-3e5796edb0c7 Details
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.
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:
INGREDIENTS AND APPEARANCE
STYPTSTIX
silver nitrate applicator stick |
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Labeler - Henry Schein Inc. (012430880) |