GRAFCO APPLICATOR 30 CM- silver nitrate stick

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A), POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)
Available from:
GF Health Products, Inc.
INN (International Name):
SILVER NITRATE
Composition:
SILVER NITRATE 52.451 mg
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
INDICATIONS:  For cauterization of skin or mucous membrane and for removing warts and granulated tissue. 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.
Authorization status:
unapproved drug other
Authorization number:
12165-200-03

GRAFCO APPLICATOR 30 CM- silver nitrate stick

GF Health Products, Inc.

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.

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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.

DOSAGE FORMS AND STRENGTHS:

Stick: 70 mg

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:

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.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL:

GRAFCO APPLICATOR 30 CM

silver nitrate stick

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:1216 5-20 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SILVER NITRATE (UNII: 9 5IT3W8 JZE) (SILVER CATION - UNII:57N7B0 K9 0 A)

SILVER NITRATE

52.451 mg

PO TASSIUM NITRATE (UNII: RU45X2JN0 Z) (NITRATE ION - UNII:T9 3E9 Y28 44)

POTASSIUM NITRATE

17.48 6 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

0 .0 42 mg

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

0 .0 21 mg

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:1216 5-

20 0 -0 3

10 0 in 1 TUBE; Type 4: Device Co ated/Impregnated/Otherwise

Co mbined with Drug

0 4/19 /19 49

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

GF Health Products, Inc.

unappro ved drug o ther

0 4/19 /19 49

Labeler -

GF Health Products, Inc. (132016168)

Registrant -

GF Health Products, Inc. (798817599)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GF Health Pro ducts, Inc.

79 8 8 1759 9

ma nufa c ture (1216 5-20 0 )

Revised: 12/2019

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