SILVER NITRATE APPLICATORS- silver nitrate applicators stick 
Arzol Chemical Company

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.

----------

Arzol Insert FrontArzol Insert Back

ARZOL® Silver Nitrate Applicators

Silver Nitrate 75%

Potassium Nitrate 25%

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.

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.

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.

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.

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.

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.

HAZARDS

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

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.

Arzol Box Packaging

Arzol® Silver Nitrate Applicators

Silver Nitrate 75%

Potassium Nitrate 25%

FOR SIMPLIFIED SILVER NITRATE THERAPY

POISON

CAUTION:

Federal law prohibits dispensing without prescription. Do not open this box or dispense packets or applicators separately.

WARNING:

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

100 APPLICATORS

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 areas 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.

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.

Arzol Inner Envelope Packaging

ARZOL® Silver Nitrate Applicators

(Silver Nitrate 75%)

(Potassium Nitrate 25%)

for Simplified Silver Nitrate Therapy

POISON

TEN (10) applicators

Caution: Federal law prohibits dispensing without prescription. Do not dispense packets or applicators separately.

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

NOT FOR RESALE

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.

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.

Arzol Vial Packaging

ARZOL Silver Nitrate Applicators

Silver Nitrate 75%

Potassium Nitrate 25%

For Simplified Silver Nitrate Therapy

Caution: Federal law prohibits dispensing without prescription. Do not open this tube or dispense applicators separately.

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

POISON

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.

SILVER NITRATE APPLICATORS 
silver nitrate applicators stick
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12870-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE25 mg  in 100 mg
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE75 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12870-0001-110 in 1 BOX01/01/1937
110 in 1 PACKET
1100 mg in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:12870-0001-2100 in 1 VIAL01/01/1937
2100 mg in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1937
Labeler - Arzol Chemical Company (002012128)
Registrant - Arzol Chemical Company (002012128)
Establishment
NameAddressID/FEIBusiness Operations
Arzol Chemical Company002012128manufacture(12870-0001)

Revised: 10/2023
Document Id: 06fcc643-ca2c-6857-e063-6394a90a67e1
Set id: 23b83457-8cbc-26f1-e054-00144ff8d46c
Version: 11
Effective Time: 20231005
 
Arzol Chemical Company