SPL v13
SPL
SPL Set ID 23b83457-8cbc-26f1-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 1995-03-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (25 mg) Silver Cation (75 mg)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 1937-01-01

Description

ARZOL® Silver Nitrate Applicators


Medication Information

Warnings and Precautions

POISON

Dosage Forms and Strengths

100 APPLICATORS

Description

for Simplified Silver Nitrate Therapy

ARZOL Silver Nitrate Applicators provide a simple and convenient means of treating small lesions of the skin and mucous membranes. On contact with living tissue, silver nitrate acts as an escharotic. Deep action is avoided by the formation of a dense surface film of coagulated albumin.

Silver nitrate is a powerful chemical germicide. Despite precipitation, it retains substantial germicidal potency even in the presence of large quantities of albuminous material, possibly by gradually redissolving the silver.

Section 43678-2

Silver Nitrate 75%

Potassium Nitrate 25%

Section 43685-7

WARNING:

Keep out of reach of children. Keep in dry and dark place. Do not use on the eyes.

Section 51945-4

Section 59845-8

Section 60561-8

In case of accidental poisoning, follow these directions:

ANTIDOTE

External:

Eye Exposure:

First: Wash out the eye with lukewarm water for at least fifteen (15) minutes then call your physician or go to your nearest Emergency Room.

Skin Exposure:

First: Wash the area very thoroughly with soap and water then call your physician.

Internal:

First: Give one (1) glass of milk or water then call your physician or go to your nearest Emergency Room.

Section 69718-5

ARZOL® Silver Nitrate Applicators

Hazards

Long continued applications to large areas may produce argyria, a slate-blue discoloration of the skin and mucous membranes.

Antidote

In case of accidental poisoning, follow these directions:

External:

Eye Exposure -- First: Wash out the eye with lukewarm water for at least fifteen (15) minutes then call your physician or go to your nearest Emergency Room.

Skin Exposure -- First: Wash the area very thoroughly with soap and water then call your physician.

Internal:

First: Give one (1) glass of milk or water then call your physician or go to your nearest Emergency Room.

Application

ARZOL may be applied direct to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated. DO NOT USE ON THE EYES.

Indications

On the skin, applications of silver nitrate are recommended for cauterization of wounds and sluggish ulcers, also for removal of granulation tissue and warts.

On mucous membranes, silver nitrate may be applied to small ulcers and aphthae in the mouth resulting from injury or stomatitis, to infected tonsils, to rectal fissures and fistulae, and to vaginal or cervical ulcerations or erosions. Epistaxis may be controlled by direct application to the site of hemorrhage within the nostrils.

Availability

ARZOL Silver Nitrate Applicators are supplied in boxes of 100 containing 10 packets each with 10 applicators; also, in plastic tubes containing 100 applicators.

Side Effects

Silver nitrate blackens the tissues to which it is applied but this discoloration gradually disappears. In the case of applicators, poisoning from ingestion is rare.

Special Properties

The combination of silver nitrate with potassium nitrate has been called toughened silver nitrate, also lunar caustic. When the tip of the applicator is impregnated with this compound, as in ARZOL, the silver nitrate can be applied quickly and conveniently to the precise area to be treated without spread of the escharotic to adjacent healthy tissues.

Exposure to light causes the silver in the tip to oxidize and turn brown in color. This discoloration does not affect the therapeutic action of the tip and the oxidized film readily dissolves when dipped in water.

Moisture has a deteriorating effect on the tip. It may cause it to break or loosen from the applicator; therefore the applicators should be kept in a dry place.

CAUTION: Silver Nitrate is a caustic compound, the improper use of which may cause chemical burns. Silver Nitrate mixes with body fluids; this mixture is caustic and tissue damage may result if not removed quickly. Contact of Silver Nitrate applicators on neonates (as in use on the umbilicus) and on thin delicate skin should be extremely short in duration.

Stability Precautions

Light causes the silver in the tip to oxidize and turn brown in color. This does not affect the therapeutic action of the tip and the oxidized film readily dissolves when dipped in water.

Moisture has a deteriorating effect on the tip. It will cause the tip to break or loosen from the applicator; therefore the applicators should be kept in a dry and dark place.

Stability Precautions

Light causes the silver in the tip to oxidize and turn brown in color. This does not affect the therapeutic action of the tip and the oxidized film readily dissolves when dipped in water. Moisture has a deteriorating effect on the tip. It will cause the tip to break or loosen from the applicator; therefore the applicators should be kept in a dry and dark place.


Structured Label Content

Dosage Forms and Strengths (34069-5)

100 APPLICATORS

Warnings and Precautions (34071-1)

POISON

Description (34089-3)

for Simplified Silver Nitrate Therapy

ARZOL Silver Nitrate Applicators provide a simple and convenient means of treating small lesions of the skin and mucous membranes. On contact with living tissue, silver nitrate acts as an escharotic. Deep action is avoided by the formation of a dense surface film of coagulated albumin.

Silver nitrate is a powerful chemical germicide. Despite precipitation, it retains substantial germicidal potency even in the presence of large quantities of albuminous material, possibly by gradually redissolving the silver.

Section 43678-2 (43678-2)

Silver Nitrate 75%

Potassium Nitrate 25%

Section 43685-7 (43685-7)

WARNING:

Keep out of reach of children. Keep in dry and dark place. Do not use on the eyes.

Section 51945-4 (51945-4)

Section 59845-8 (59845-8)

Section 60561-8 (60561-8)

In case of accidental poisoning, follow these directions:

ANTIDOTE

External:

Eye Exposure:

First: Wash out the eye with lukewarm water for at least fifteen (15) minutes then call your physician or go to your nearest Emergency Room.

Skin Exposure:

First: Wash the area very thoroughly with soap and water then call your physician.

Internal:

First: Give one (1) glass of milk or water then call your physician or go to your nearest Emergency Room.

Section 69718-5 (69718-5)

ARZOL® Silver Nitrate Applicators

Hazards (HAZARDS)

Long continued applications to large areas may produce argyria, a slate-blue discoloration of the skin and mucous membranes.

Antidote (ANTIDOTE)

In case of accidental poisoning, follow these directions:

External:

Eye Exposure -- First: Wash out the eye with lukewarm water for at least fifteen (15) minutes then call your physician or go to your nearest Emergency Room.

Skin Exposure -- First: Wash the area very thoroughly with soap and water then call your physician.

Internal:

First: Give one (1) glass of milk or water then call your physician or go to your nearest Emergency Room.

Application (APPLICATION)

ARZOL may be applied direct to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated. DO NOT USE ON THE EYES.

Indications (INDICATIONS)

On the skin, applications of silver nitrate are recommended for cauterization of wounds and sluggish ulcers, also for removal of granulation tissue and warts.

On mucous membranes, silver nitrate may be applied to small ulcers and aphthae in the mouth resulting from injury or stomatitis, to infected tonsils, to rectal fissures and fistulae, and to vaginal or cervical ulcerations or erosions. Epistaxis may be controlled by direct application to the site of hemorrhage within the nostrils.

Availability (AVAILABILITY)

ARZOL Silver Nitrate Applicators are supplied in boxes of 100 containing 10 packets each with 10 applicators; also, in plastic tubes containing 100 applicators.

Side Effects (SIDE EFFECTS)

Silver nitrate blackens the tissues to which it is applied but this discoloration gradually disappears. In the case of applicators, poisoning from ingestion is rare.

Special Properties (SPECIAL PROPERTIES)

The combination of silver nitrate with potassium nitrate has been called toughened silver nitrate, also lunar caustic. When the tip of the applicator is impregnated with this compound, as in ARZOL, the silver nitrate can be applied quickly and conveniently to the precise area to be treated without spread of the escharotic to adjacent healthy tissues.

Exposure to light causes the silver in the tip to oxidize and turn brown in color. This discoloration does not affect the therapeutic action of the tip and the oxidized film readily dissolves when dipped in water.

Moisture has a deteriorating effect on the tip. It may cause it to break or loosen from the applicator; therefore the applicators should be kept in a dry place.

CAUTION: Silver Nitrate is a caustic compound, the improper use of which may cause chemical burns. Silver Nitrate mixes with body fluids; this mixture is caustic and tissue damage may result if not removed quickly. Contact of Silver Nitrate applicators on neonates (as in use on the umbilicus) and on thin delicate skin should be extremely short in duration.

Stability Precautions (STABILITY PRECAUTIONS)

Light causes the silver in the tip to oxidize and turn brown in color. This does not affect the therapeutic action of the tip and the oxidized film readily dissolves when dipped in water.

Moisture has a deteriorating effect on the tip. It will cause the tip to break or loosen from the applicator; therefore the applicators should be kept in a dry and dark place.

Stability Precautions

Light causes the silver in the tip to oxidize and turn brown in color. This does not affect the therapeutic action of the tip and the oxidized film readily dissolves when dipped in water. Moisture has a deteriorating effect on the tip. It will cause the tip to break or loosen from the applicator; therefore the applicators should be kept in a dry and dark place.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)