![GRAFCO APPLICATOR 15 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 30 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 45 CM (SILVER NITRATE) STICK [GF HEALTH PRODUCTS, INC.]](https://medic.hrt.org//dailymed/images/0fff668c-8b5c-4b52-a740-7a078d413620/12165.jpg)
| NDC | 12165-100-03, 12165-200-03, 12165-300-01 |
| Set ID | 0fff668c-8b5c-4b52-a740-7a078d413620 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | GF Health Products, Inc. |
| Generic Name | |
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- COMPONENTS
- INDICATIONS & USAGE
- INSTRUCTIONS FOR USE
- CONTRAINDICATIONS
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USER SAFETY WARNINGS
WARNINGS: KEEP OUT OF REACH OF CHILDREN. The active ingredients are poisonous and may be fatal when ingested in sufficient
doses. The symptoms include toxic gastroenteritis, which may lead to coma, convulsion, paralysis and profound alteration of respiration.
If poisoning occurs, consult a physician. In case of eye contact, hold eyes open and immediately flush thoroughly with water for at least 15
minutes and consult a physician. - WARNINGS
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PRECAUTIONS
PRECAUTION: Prolonged ingestion or absorption of silver compounds (organic or inorganic) whether originating industrially or
therapeutically leads to disposition of silver in connective tissues, producing a slate-blue discoloration of the skin known as argyria.
This discoloration may also appear on mucous membranes such as the margins of gums. The sclera of the eye is also stained. The nature
of the pigment is not definitely known, it may be metallic silver or oxide. This discoloration exists throughout life but does not cause any
systematic symptoms. While small patches may be removed, this method is so tedious and painful as to be impractical for large areas. -
MECHANISM OF ACTION
ACTION: Silver nitrate commonly employed as a caustic antiseptic and an astringent. Potassium nitrate has been used as a topical
antiseptic on mucous membranes. The degree of action depends upon the concentration employed and the period of time during which
the compound is allowed to act. The silver nitrate is precipitated by chloride thus washing with a solution of sodium chloride can quickly
stop the action of silver ions. - STORAGE AND HANDLING
- USER SAFETY WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GRAFCO APPLICATOR 15 CM
silver nitrate stickProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12165-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 38.21 mg Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152) Potassium Nitrate 12.74 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12165-100-03 12 in 1 BOX 1 100 in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/19/1949 GRAFCO APPLICATOR 30 CM
silver nitrate stickProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12165-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 52.451 mg Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152) Potassium Nitrate 17.486 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12165-200-03 100 in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/19/1949 GRAFCO APPLICATOR 45 CM
silver nitrate stickProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12165-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 73.4314 mg Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152) Potassium Nitrate 24.4804 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12165-300-01 1 in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/19/1949 Labeler - GF Health Products, Inc. (132016168) Registrant - GF Health Products, Inc. (132016168) Establishment Name Address ID/FEI Business Operations GF Health Products, Inc. 798817599 manufacture
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