SPL v3
SPL
SPL Set ID d7622ce1-a327-4c81-b6c0-c9e8dbd39565
Route
TOPICAL
Published
Effective Date 2020-01-03
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silver Cation (73.4314 mg) Nitrate Ion (24.4804 mg)
Inactive Ingredients
Hydrochloric Acid Sodium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 1949-04-19

Description

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

Indications and Usage

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

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.

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. 

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.


Medication Information

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. 

Indications and Usage

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

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.

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.

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 and Usage:

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

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. 

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.

Dosage Forms and Strengths:

Stick: 98 mg

Package Label Principal Display Panel:


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.

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 and Usage: (INDICATIONS AND USAGE:)

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

Warnings and Precautions: (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. 

Dosage and Administration: (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.

Dosage Forms and Strengths: (DOSAGE FORMS AND STRENGTHS:)

Stick: 98 mg

Package Label Principal Display Panel: (PACKAGE LABEL PRINCIPAL DISPLAY PANEL:)


Advanced Ingredient Data


Raw Label Data

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