Tanac Oral Pain Reliever
Benzocaine
Leosons Overseas Corp
Human Otc Drug
NDC 69626-0049Tanac Oral Pain Reliever also known as Benzocaine is a human otc drug labeled by 'Leosons Overseas Corp'. National Drug Code (NDC) number for Tanac Oral Pain Reliever is 69626-0049. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Tanac Oral Pain Reliever drug includes Benzocaine - 10 g/100mL . The currest status of Tanac Oral Pain Reliever drug is Active.
Drug Information:
| Drug NDC: | 69626-0049 |
| 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: | Tanac Oral Pain Reliever |
| 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: | Benzocaine |
| 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: | 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: | BENZOCAINE - 10 g/100mL
|
| 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: | 01 Jan, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 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. |
| 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. |
| RxCUI: | 583152
1053339
|
| 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. |
| NUI: | N0000185508
N0000175629
N0000184306
M0000728
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | U3RSY48JW5
|
| 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. |
| Pharmacologic Class EPC: | Standardized Chemical Allergen [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Allergens [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Allergens [CS]
Cell-mediated Immunity [PE]
Increased Histamine Release [PE]
Standardized Chemical Allergen [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69626-0049-4 | 1 BOTTLE in 1 CARTON (69626-0049-4) / 13.3 mL in 1 BOTTLE | 01 Jan, 2015 | 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 ingredient purpose benzocaine 10%........................................................ oral pain reliever
Product Elements:
Tanac oral pain reliever benzocaine saccharin sodium saccharin tannic acid peppermint oil peppermint propylene glycol benzalkonium chloride polyethylene glycol 400 benzocaine benzocaine
Indications and Usage:
Uses temporarily relieves pain due to canker sores cold sores fever blisters minor irritations or injury of the mouth and gums
Warnings:
Warnings for oral use only. methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other âcaineâ anesthetics. if a skin reaction occurs, stop use and seek medical help right away. flammability warning: keep away from fire or flame. stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days symptoms clear up and occur again within a few days irritation, pain or redness persists or worsens swelling, rash, o
Read more...r fever develops if pregnant or breast-feeding, ask a health professional before use. do not use for teething in children under 2 years of age when using this product avoid contact with the eyes do not use more than directed do not use for more than 7 days unless directed by a dentist or doctor keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other âcaineâ anesthetics. if a skin reaction occurs, stop use and seek medical help right away.
Flammability warning: keep away from fire or flame.
Do Not Use:
Warnings for oral use only. methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other âcaineâ anesthetics. if a skin reaction occurs, stop use and seek medical help right away. flammability warning: keep away from fire or flame. stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days symptoms clear up and occur again within a few days irritation, pain or redness persists or worsens swelling, rash, or fever develops if pregnant or breast-feeding, ask a health professional before use. do not use for teething in children under 2 years of age when using this product avoid contact with the eyes do not use more than directed do not use for more than 7 days unless directed by a dentist or doctor keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other âcaineâ anesthetics. if a skin reaction occurs, stop use and seek medical help right away.
Flammability warning: keep away from fire or flame.
When Using:
When using this product avoid contact with the eyes do not use more than directed do not use for more than 7 days unless directed by a dentist or doctor
Dosage and Administration:
Directions apply product with cotton swab or clean fingertip to the affected area adults and children 2 years of age and older : use up times 4 times daily or as directed by a dentist or doctor. children should be supervised in the use of this product. children under 2 years of age : do not use
Package Label Principal Display Panel:
Principal display panel canker sores gum irritations cold sores fever blisters tanac ® benzocaine 10% oral pain reliever no sting liquid 0.45 fl oz. (13.3ml) tanac box
Further Questions:
Questions? 1-855-452-9500 or email at info@leosonsintl.com