FDA Label for Silver Nitrate Applicators
View Indications, Usage & Precautions
Silver Nitrate Applicators Product Label
The following document was submitted to the FDA by the labeler of this product Arzol Chemical Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Statement Of Identity
ARZOL® Silver Nitrate Applicators
Arzol® Silver Nitrate Applicators
ARZOL® Silver Nitrate Applicators
ARZOL Silver Nitrate Applicators
Dosage Forms & Strengths
Silver Nitrate 75%
Potassium Nitrate 25%
Silver Nitrate 75%
Potassium Nitrate 25%
(Silver Nitrate 75%)
(Potassium Nitrate 25%)
Silver Nitrate 75%
Potassium Nitrate 25%
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.
FOR SIMPLIFIED SILVER NITRATE THERAPY
for Simplified Silver Nitrate Therapy
For Simplified Silver Nitrate Therapy
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.
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.
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.
Package Label.Principal Display Panel
Warnings
POISON
CAUTION:
Federal law prohibits dispensing without prescription. Do not open this box or dispense packets or applicators separately.
POISON
Caution: Federal law prohibits dispensing without prescription. Do not dispense packets or applicators separately.
NOT FOR RESALE
Caution: Federal law prohibits dispensing without prescription. Do not open this tube or dispense applicators separately.
POISON
Warnings And Precautions
WARNING:
Keep out of reach of children. Keep in dry and dark place. Do not use on the eyes.
Warning: Do not use on the eyes. Keep out of reach of children. Keep in a dry and dark place.
Warning: Do not use on the eyes. Keep out of reach of children. Keep in a dry and dark place.
How Supplied
100 APPLICATORS
TEN (10) applicators
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.
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.
Other Safety Information
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.
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