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| Product NDC Code | 69626-0049 | ||||
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| Drug Name | Tanac oral pain reliever |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 583152, 1053339 |
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| Application Number | M022 | ||||
| Labeler Name | Leosons Overseas Corp | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients & Purposes Active Ingredient Purpose Benzocaine 10%........................................................ Oral pain reliever
| Benzocaine 10%........................................................ | Oral pain reliever |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, peppermint oil, polyethylene glycol 400, propylene glycol, sodium saccharin, tannic acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves pain due to canker sores cold sores fever blisters minor irritations or injury of the mouth and gums
Purpose
Information about the drug product’s indications for use.Active Ingredient Purpose Benzocaine 10%........................................................ Oral pain reliever
| Benzocaine 10%........................................................ | Oral pain reliever |
Spl product data elements
Usually a list of ingredients in a drug product.TANAC Oral Pain Reliever Benzocaine SACCHARIN SODIUM SACCHARIN TANNIC ACID PEPPERMINT OIL PEPPERMINT PROPYLENE GLYCOL BENZALKONIUM CHLORIDE POLYETHYLENE GLYCOL 400 BENZOCAINE BENZOCAINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for teething in children under 2 years of age
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 20 - 25°C (68 - 77°F) do not use if imprinted safety seal is torn, broken or missing prior to opening keep carton for full drug facts
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-855-452-9500 or email at [email protected]
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 “caine” 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 “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.
Flammability warning: Keep away from fire or flame.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API