Label: REPARA SILVER NITRATE APPLICATORS- silver nitrate stick
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Contains inactivated NDC Code(s)
NDC Code(s): 68345-100-60 - Packager: PSS World Medical, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated October 26, 2012
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- Active Ingredients
- CAUTION:
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DOSAGE & ADMINISTRATION:
Prior to use, the applicator stick may be bent or shaped to allow easier access to the target area. The medicated end of the applicator should be moistened in clean water and applied to the affected tissue. One applicator is normally sufficient for each application. The strength of the action is controlled by the amount of water used to moisten the tip. The applicator action can be stopped by washing the area with a saline solution (0.9% sodium chloride).
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CONTRAINDICATIONS & ANTIDOTES:
Repara® Silver Nitrate Applicators must not be used for genital warts. Continued application to mucous membranes and open wounds leads to argyria, a blush-black discoloration of the skin due to depositions of granules of silver compounds in the connective tissues. This condition persists indefinitely or disappears very slowly. Poisoning by oral ingestion is unlikely with the quantities involved, but treatment for poisoning is the immediate ingestion of large amounts of salt water followed by an emetic. Then administer a dose of Epsom salts followed with milk. Immediately call a physician.
- CAUTION:
- STORAGE:
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- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
REPARA SILVER NITRATE APPLICATORS
silver nitrate stickProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68345-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 75 mg POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 25 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68345-100-60 10 in 1 CASE 1 10 in 1 BOX 1 100 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/26/2012 Labeler - PSS World Medical, Inc. (101822682) Registrant - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Bray Group Limited 217504463 manufacture(68345-100)
