GRAFCO SILVER NITRATE (75% SILVER NITRATE, 25% POTASSIUM NITRATE): Package Insert and Label Information

GRAFCO SILVER NITRATE (75% SILVER NITRATE, 25% POTASSIUM NITRATE)- potassium nitrate and silver nitrate stick
HF Acquisition Co LLC, DBA HealthFirst

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.

INDICATIONS & USAGE

INDICATIONS: For cauterization of skin or mucous membrane and for removing warts and granulated tissue.

DOSAGE & 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 & 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 returned for disposal to: GF Health Products, Inc., 33 Plan Way, Bldg. # 2, Warwick, RI 02886, or disposed of according to applicable federal, state and local regulations.

HOW SUPPLIED

NDC 51662-1611-1

GRAFCO SILVER NITRATE 6″ APPLICATORS (75% SILVER NITRATE, 25% POTASSIUM NITRATE) 100 PER TUBE

HF Acquisition Co LLC, DBA HealthFirst
11629 49th Pl W.

Mukilteo, WA 98275

PRINCIPAL DISPLAY PANEL — NDC 51662-1611-1

51662-1611-1 Serialized Tube Labeling

Serialized Label
(click image for full-size original)

Tube Labeling

Tube Label
(click image for full-size original)
GRAFCO SILVER NITRATE (75% SILVER NITRATE, 25% POTASSIUM NITRATE)
grafco silver nitrate (75% silver nitrate, 25% potassium nitrate) stick
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1611(NDC:12165-100)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 12.74 mg
SILVER NITRATE (SILVER CATION) SILVER NITRATE 38.21 mg
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID 0.036 mg
SODIUM CHLORIDE 0.0153 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1611-1 100 STICK in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/10/2022
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1611)

Revised: 08/2022 HF Acquisition Co LLC, DBA HealthFirst

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