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| Product NDC Code | 55670-810 | ||||
|---|---|---|---|---|---|
| Drug Name | Anesthetic |
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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 | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 238910 | ||||
| Application Number | part356 | ||||
| Labeler Name | Moore Medical LLC | ||||
| 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 (in each gram) Benzocaine 20.0% (w/w)
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 Adults and children( 2 years and older): dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor. Children under 2 years of age: Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients PEG 400, PEG 3350, peppermint oil, 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 For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.
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.Anesthetic benzocaine POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 PEPPERMINT OIL 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.Moore Medical Orasol Gel 20% Label mooremedical Supporting Health & Care Reorder No. 82474 UPN# 0-0607415-82474-2 MooreBrand® Orasol Gel 20% 75 Packets Each Packet Net. Wt. 0.75gm Temporary relief of minor pain and sore mouth. Distributed by: Moore Medical LLC Farmington, CT 06032 Manufacturer 21305178 Made in India and USA Moore Medical
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 if packet is torn, cut, or opened Store at room temperature, 59° to 86°F (15° to 30°C) tamper evident sealed packets
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 - any teething related indication will not be ab appropriate use of this product in children under 2 years of age for more than 7 days unless directed by a 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 If accidentally swallowed, 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? Call 800.234.1464
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 does not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, fever or other allergic reaction 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 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 For oral use only. Do not exceed recommended dosage. 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 the blood. This can occur even if you have used this product before. Stop use and seek medical attention if you or a child in your care develops: pale, gray or blue colored skin (cyanosis) rapid heart rate dizziness or lightheadedness headache shortness of breath 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 occrs, stop use and seek medical help right away. Do not use for teething - any teething related indication will not be ab appropriate use of this product in children under 2 years of age for more than 7 days unless directed by a doctor Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, fever or other allergic reaction develops When using this product avoid contact with eyes Keep out of reach of children If accidentally swallowed, 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