Strong Iodine Solution
Safecor Health, Llc
Human Prescription Drug
NDC 48433-230Strong Iodine Solution is a human prescription drug labeled by 'Safecor Health, Llc'. National Drug Code (NDC) number for Strong Iodine Solution is 48433-230. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Strong Iodine Solution drug includes Iodine - 700 mg/mL Potassium Iodide - 1400 mg/mL . The currest status of Strong Iodine Solution drug is Active.
Drug Information:
| Drug NDC: | 48433-230 |
| 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: | Strong Iodine Solution |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Strong Iodine Solution |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Safecor Health, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| 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: | IODINE - 700 mg/mL
POTASSIUM IODIDE - 1400 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 20 Sep, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| 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: | Safecor Health, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 204913
|
| 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: | 0348433230152
|
| UPC stands for Universal Product Code. |
| UNII: | 9679TC07X4
1C4QK22F9J
|
| 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 |
|---|
| 48433-230-15 | 14 mL in 1 BOTTLE (48433-230-15) | 20 Sep, 2008 | 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:
Strong iodine solution strong iodine solution iodine iodine potassium iodide iodide ion water
Indications and Usage:
Indications strong iodine solution, containing 5 percent of iodine and 10 percent of potassium iodide, is employed in the prophylaxis of simple and colloid goiters and in the treatment of exophthalmic goiter. it can be used alone as a preoperative preparation but is now most commonly used concomitantly with propylthiouracil and other antithyroid drugs. when used with these drugs, strong iodine solution produces involution of the hyperplastic gland thus making a less triable and vascular gland for thyroidectomy. in addition, it has an additive antithyroid action that helps make the patient enthyroid faster than if the antithyroid drugs were used alone.
Warnings:
Warnings prolonged therapy may cause iodism. use in pregnancy: the drug readily crosses the placental barrier and may affect the fetus if used during pregnancy.
Dosage and Administration:
Dosage strong iodine solution is for oral use only. the usual dosage of strong iodine solution is 2 to 6 drops (0.1 to 0.3 ml) three times daily taken in water after meals for two or three weeks prior to operation. in thyroid crisis the dosage is 1 ml three times a day.
Contraindications:
Contraindications the use of iodides may be contraindicated in patients with tuberculosis because it is believed they may cause a breakdown of healing lesions. the use of iodides is contraindicated in patients with iododerma, laryngeal edema, and swelling of salivary glands or increased salivation upon previous exposure to iodides. strong iodine solution is ineffective in the treatment of postoperative thyroid crisis.
Adverse Reactions:
Adverse reactions ingestion of large quantities of strong iodine solution may cause abdominal pain, nausea, vomiting and diarrhea. average doses may cause skin rash.
Description:
Description iodine 5g, potassium iodide 10g, in enough purified water to make 100 ml.
How Supplied:
How supplied bottles of 14 ml, amber glass with lined plastic closures. accompanying each bottle is a glass dropper which should be used when the solution is ready to be dispensed to minimize any loss of free iodine through the bulb of the dropper.
Package Label Principal Display Panel:
âââprincipal display panelâââ do not use in eyes ndc 48433-230-15 rx only safecor health strong iodine solution u.s.p. (lugol's solution) net contents 14 ml product label