Label: SILVER NITRATE APPLICATORS stick

  • NDC Code(s): 12870-0001-1, 12870-0001-2
  • Packager: Arzol Chemical Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated January 20, 2020

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  • INSTRUCTIONS FOR USE

    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.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    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.

  • PRINCIPAL DISPLAY PANEL

    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.

  • INGREDIENTS AND APPEARANCE
    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)