Nice Sore Throat Spearmint
Phenol
Leosons Overseas Corp
Human Otc Drug
NDC 69626-0048Nice Sore Throat Spearmint also known as Phenol is a human otc drug labeled by 'Leosons Overseas Corp'. National Drug Code (NDC) number for Nice Sore Throat Spearmint is 69626-0048. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Nice Sore Throat Spearmint drug includes Phenol - 1.4 g/177mL . The currest status of Nice Sore Throat Spearmint drug is Active.
Drug Information:
| Drug NDC: | 69626-0048 |
| 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: | Nice Sore Throat Spearmint |
| 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: | Phenol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Leosons Overseas Corp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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: | PHENOL - 1.4 g/177mL
|
| 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: | OTC MONOGRAPH NOT FINAL |
| 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: | 07 Mar, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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. |
| Application Number: | part356 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Leosons Overseas Corp
|
| 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. |
| UPC: | 0641528000488
|
| UPC stands for Universal Product Code. |
| UNII: | 339NCG44TV
|
| 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 |
|---|
| 69626-0048-6 | 177 mL in 1 BOTTLE, SPRAY (69626-0048-6) | 07 Mar, 2014 | 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:
Active ingredients purposes phenol 1.4% oral anesthetic/ analgesic
Product Elements:
Nice sore throat spearmint phenol propylene glycol glycerin d&c green no. 5 water saccharin sodium saccharin fd&c green no. 3 d&c yellow no. 10 phenol phenol
Indications and Usage:
Uses for temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.
Warnings:
Warnings sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. consult doctor promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. when using this product do not use more than directed. stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops difficulty in breathing occurs if pregnant or breast feeding, ask a health professional before use. keep this and all drugs out of reach of children. in case of accidental overdose, seek professional assistance or contact a poison control center right away.
When Using:
When using this product do not use more than directed.
Dosage and Administration:
Directions apply to the affected area allow to remain in place for at least 15 seconds, then spit out use every 2 hours or as directed by a doctor or dentist age dose adults and children 12 years of age and older for each application, spray 5 times children 3 to under 12 years should be supervised in use of this product for each application, spray 3 times children under 3 years of age consult a doctor or dentist
Stop Use:
Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops difficulty in breathing occurs
Package Label Principal Display Panel:
Principal display panel sugar free alcohol free aspirin free n'ice® p h e n o l / o r a l a n e s t h e t i c sore throat spray fast acting, long lasting relief of minor sore throat and mouth pain spearmint flavor 6 fl oz (177 ml) nice throat spearmint
Further Questions:
Questions? 1-855-452-9500 or email at info@leosonsintl.com