{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Silver Nitrate Applicators Silver Nitrate Applicators POTASSIUM NITRATE NITRATE ION SILVER NITRATE SILVER CATION" ], "instructions_for_use": [ "Arzol Insert Front Arzol 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." ], "statement_of_identity": [ "ARZOL® Silver Nitrate Applicators", "Arzol® Silver Nitrate Applicators", "ARZOL® Silver Nitrate Applicators", "ARZOL Silver Nitrate Applicators" ], "dosage_forms_and_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" ], "general_precautions": [ "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_and_usage": [ "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." ], "dosage_and_administration": [ "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." ], "warnings": [ "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.", "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" ], "other_safety_information": [ "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.", "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.", "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: 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." ], "adverse_reactions": [ "HAZARDS Long continued applications to large areas may produce argyria, a slate-blue discoloration of the skin and mucous membranes." ], "how_supplied": [ "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.", "100 APPLICATORS", "TEN (10) applicators" ], "package_label_principal_display_panel": [ "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." ], "warnings_and_cautions": [ "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." ], "storage_and_handling": [ "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." ], "set_id": "23b83457-8cbc-26f1-e054-00144ff8d46c", "id": "424dba13-53c3-5abf-e063-6394a90a4722", "effective_time": "20251029", "version": "13", "openfda": { "brand_name": [ "Silver Nitrate Applicators" ], "generic_name": [ "SILVER NITRATE APPLICATORS" ], "manufacturer_name": [ "Arzol Chemical Company" ], "product_ndc": [ "12870-0001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "POTASSIUM NITRATE", "SILVER NITRATE" ], "rxcui": [ "1117536" ], "spl_id": [ "424dba13-53c3-5abf-e063-6394a90a4722" ], "spl_set_id": [ "23b83457-8cbc-26f1-e054-00144ff8d46c" ], "package_ndc": [ "12870-0001-1", "12870-0001-2" ], "is_original_packager": [ true ], "unii": [ "RU45X2JN0Z", "95IT3W8JZE" ] } } ] }