Label: GRAFCO APPLICATOR 15 CM- silver nitrate stick
- NDC Code(s): 12165-100-01
- Packager: GF Health Products, 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 January 19, 2021
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- 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.
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.
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.
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL:
INGREDIENTS AND APPEARANCE
GRAFCO APPLICATOR 15 CM
silver nitrate stick
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12165-100 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) 0.036 mg SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0153 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12165-100-01 100 in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 04/19/1949 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/19/1949 Labeler - GF Health Products, Inc. (132016168) Registrant - GF Health Products, Inc. (798817599) Establishment Name Address ID/FEI Business Operations GF Health Products, Inc. 798817599 manufacture(12165-100)