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| Product NDC Code | 73492-717 | ||||
|---|---|---|---|---|---|
| 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 | ALAINA HEALTHCARE PRIVATE LIMITED | ||||
| 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.Drug Facts Active ingredients Purpose Benzocaine 20%....................................................................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: adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age adult supervision should be given in the use of this product children under 2 years of age do not use For denture irritation: apply thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting Other information store at 20-25°C (68-77°F) do not refrigerate
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, 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 temporarily relieves pain associated with the following mouth and gum irritations: toothache canker sores minor dental procedures dentures sore gums braces
Spl product data elements
Usually a list of ingredients in a drug product.Oral pain relief benzocaine BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 PROPYLENE GLYCOL 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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH ORAL PAIN RELIEF GEL FAST ACTING Benzocaine 20% pain relieving gel NET WT 0.5 OZ (14g) label label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.When using this product: avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist Stop use and ask doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness lasts or worsens swelling, rash, or fever develops
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 more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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. Do not use: for teething in children under 2 years of age
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