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| Product NDC Code | 57896-139 | ||||
|---|---|---|---|---|---|
| Drug Name | Oral pain relief |
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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 | GEL | ||||
| RxCUI drug identifier | 238910 | ||||
| Application Number | M022 | ||||
| Labeler Name | GERI-CARE PHARMACEUTICAL 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 Ingredient Benzocaine 20%
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 • do not exceed recommended dosage • do not use for more than 7 days unless told to do so by a dentist or doctor • adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist • children between 2 and 12 years of age: adult supervision should be given in 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 Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic 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 temporary relieves pain associated with the following mouth and gum irritations: • toothache • sore gums • canker sores • braces • minor dental procedures • dentures
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Oral Pain Relief BENZOCAINE POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 1500 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM SORBIC ACID 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.1
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
Other information • do not use tube if it is cut prior to opening • to open tube, cut open tip of tube on score mark with scissors • store at a controlled room temperature 68º-77ºF (20º-25ºC)
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 • more than recommended • for more than 7 days unless told to do so by a dentist or doctor
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-800-540-3765
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
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
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 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. Do not use • for teething • in children under 2 years of age • more than recommended • for more than 7 days unless told to do so by a dentist or doctor When using this product • avoid contact with the eyes 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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