Grafco Applicator 30 Cm
Silver Nitrate
Gf Health Products, Inc.
Human Prescription Drug
NDC 12165-200Grafco Applicator 30 Cm also known as Silver Nitrate is a human prescription drug labeled by 'Gf Health Products, Inc.'. National Drug Code (NDC) number for Grafco Applicator 30 Cm is 12165-200. This drug is available in dosage form of Stick. The names of the active, medicinal ingredients in Grafco Applicator 30 Cm drug includes Potassium Nitrate - 17.486 mg/1 Silver Nitrate - 52.451 mg/1 . The currest status of Grafco Applicator 30 Cm drug is Active.
Drug Information:
| Drug NDC: | 12165-200 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Grafco Applicator 30 Cm |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Grafco |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | APPLICATOR 30 CM |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Silver Nitrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Gf Health Products, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Stick |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POTASSIUM NITRATE - 17.486 mg/1
SILVER NITRATE - 52.451 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 19 Apr, 1949 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GF Health Products, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1117536
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0312165200035
|
| UPC stands for Universal Product Code. |
| UNII: | RU45X2JN0Z
95IT3W8JZE
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 12165-200-03 | 100 STICK in 1 TUBE (12165-200-03) | 19 Apr, 1949 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Grafco applicator 30 cm silver nitrate silver nitrate silver cation potassium nitrate nitrate ion hydrochloric acid sodium chloride
Indications and Usage:
Indications and usage: indications: for cauterization of skin or mucous membrane and for removing warts and granulated tissue.
Warnings and Cautions:
Warnings and precautions: warning: 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, immediately consult a physician. warning: do not use on the eyes. in case of eye contact, hold eyes open and immediately flush thoroughly with water for at least 15 minutes and consult a physician. caution: silver nitrate is a caustic substance. chemical burns may result from inappropriate use of product. ⢠wear chemical resistant gloves while using this product. wear other appropriate personal protective equipment as needed. ⢠take care to confine the silver nitrate to the area being treated by using an appropriate physical or chemical barrier to prevent staining or burning of untreated tissue. ⢠skin contact time with applicators should be minimal when used on thin del
Read more...icate skin or neonates. ⢠avoid prolonged contact with skin or other surfaces since staining may occur. caution: federal law prohibits dispensing without prescription.
Dosage and Administration:
Dosage and administration moisten the applicator tip with distilled, deionized or purified water and apply the silver nitrate to the affected area by holding, rubbing, or rotating the tip along the affected tissue. the strength of the action is controlled by the dilution with distilled, deionized or purified water. one silver nitrate applicator is generally sufficient for each application. the action of the silver nitrate can be stopped by washing the area with saline solution (0.9% sodium chloride). using saline solution to wet the applicator tips, or residual saline from wound flushing/washing will interfere with the action of silver nitrate resulting in cauterization failure. only use distilled, deionized or purified water to wet applicator tips. blot dry wounds that have been flushed/washed with saline prior to applying silver nitrate.
Dosage Forms and Strength:
Dosage forms and strengths: stick: 70 mg
Contraindications:
Contraindications: silver salts stain tissue black due to deposition of reduced silver. the stain gradually disappears within a period of two weeks. prolonged ingestion or absorption of silver compounds leads to deposition 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.
Package Label Principal Display Panel:
Package label principal display panel: image description