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NDC 12165-0100-01 GRAFCO 12.74; 38.21 mg/1; mg/1 Details
GRAFCO 12.74; 38.21 mg/1; mg/1
GRAFCO is a TOPICAL STICK in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GF Health Products, Inc.. The primary component is POTASSIUM NITRATE; SILVER NITRATE.
Product Information
NDC | 12165-0100 |
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Product ID | 12165-100_2649734d-3624-4cf6-9fa7-b0cec914c214 |
Associated GPIs | 90509902406340 |
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 | GRAFCO |
Proprietary Name Suffix | APPLICATOR 15 CM |
Non-Proprietary Name | Silver Nitrate |
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 | GF Health Products, 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 12165-0100-01 (12165010001)
NDC Package Code | 12165-100-01 |
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Billing NDC | 12165010001 |
Package | 100 STICK in 1 TUBE (12165-100-01) |
Marketing Start Date | 1949-04-19 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 41a82a8c-9a4a-4610-a115-8d8c72a25b1e 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
GRAFCO
APPLICATOR 15 CM
silver nitrate stick |
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Labeler - GF Health Products, Inc. (132016168) |
Registrant - GF Health Products, Inc. (798817599) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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GF Health Products, Inc. | 798817599 | manufacture(12165-100) |