Albothyl
Policresulen Solution
Lydia Co., Ltd.
Human Otc Drug
NDC 72988-0035Albothyl also known as Policresulen Solution is a human otc drug labeled by 'Lydia Co., Ltd.'. National Drug Code (NDC) number for Albothyl is 72988-0035. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Albothyl drug includes Policresulen - 720 mg/mL . The currest status of Albothyl drug is Active.
Drug Information:
| Drug NDC: | 72988-0035 |
| 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: | Albothyl |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Policresulen Solution |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lydia Co., Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | POLICRESULEN - 720 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: | 23 Jan, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 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, 2024 |
| 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: | Lydia Co., Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 6I19M5GB0G
|
| 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 |
|---|
| 72988-0035-1 | 5 mL in 1 BOTTLE (72988-0035-1) | 23 Jan, 2023 | 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. |
Purpose:
Oral debriding agent/oral wound cleanser for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums such as mouth burns, cheek bites and toothbrush abrasions. cleans minor mouth wounds by removing foreign materials that can impede the healing process
Product Elements:
Albothyl policresulen solution water policresulen policresulen
Indications and Usage:
Adults and children 2 years of age and older: rinse half of a capful around in the mouth over affected area for at least 1 minute, then spit out. use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician. children under 12 years of age should be supervised in the use of the product. children under 2 years of age: consult a dentist or physician. to open child safety cap, squeeze smooth sides while turning. reclose tightly
Warnings:
Do not use this product for more than 7 days unless directed by a dentist or physician. when using this product, do not swallow. stop use and ask a doctor if. sore mouth symptoms do not improve within 7 days. irritation, pain or redness persists or worsens. swelling, rash or fever develops. keep out of reach of children. if more than used for rinsing is accidentally swallowed, get medical help or contact a poison control center right away. do not use if carton is opened. do not use if printed band on bottle is broken or missing
Dosage and Administration:
For oral use
Package Label Principal Display Panel:
Label