Grafco Silver Nitrate 6" Applicators (75% Silver Nitrate, 25% Potassium Nitrate) 100 Per Tube

Grafco Silver Nitrate 6" Applicators (75% Silver Nitrate, 25% Potassium Nitrate) 100 Per Tube
SPL v2
SPL
SPL Set ID e5ebf7aa-fbe5-45b1-e053-2a95a90a5cbf
Route
TOPICAL
Published
Effective Date 2022-08-10
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (12.74 mg) Silver Cation (0.036 mg)
Inactive Ingredients
Hydrochloric Acid Sodium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-08-10

Description

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

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.

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


Medication Information

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.

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

Description

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

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.

Indications & Usage

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

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.

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.

Principal Display Panel Ndc 51662 1611 1

51662-1611-1 Serialized Tube Labeling

Tube Labeling


Structured Label Content

Storage (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 (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 (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

Contraindications (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.

Indications & Usage (INDICATIONS & USAGE)

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

Warnings & Precautions (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.

Dosage & Administration (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.

Principal Display Panel Ndc 51662 1611 1 (PRINCIPAL DISPLAY PANEL - NDC 51662-1611-1)

51662-1611-1 Serialized Tube Labeling

Tube Labeling


Advanced Ingredient Data


Raw Label Data

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