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| Product NDC Code | 52000-060 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 1595155 | ||||||
| Application Number | part356 | ||||||
| Labeler Name | Universal Distribution Center 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 Ingredients Benzocaine 20% Benzalkonium Chloride 0.1%
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 small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider ■ children under 12 years of age: 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 ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid, purified water, FD&C Yellow#5, FD&C Red#40
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.Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation
Purpose
Information about the drug product’s indications for use.Purpose Oral pain reliever Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Oral Pain Relief Benzocaine and Benzalkonium Chloride AMMONIUM GLYCYRRHIZATE POLYETHYLENE GLYCOL, UNSPECIFIED SACCHARIN SODIUM SORBIC ACID WATER FD&C YELLOW NO. 5 FD&C RED NO. 40 BENZOCAINE BENZOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM
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 Oral Pain Relief Gel NET WT. 0.5 oz (14 g) image description
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.Other information ■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted ■ do not use continuously ■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening
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 ■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider
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 or allergic reaction get medical help or contact a Poison Control Center right away.
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 physician if ■ swelling, rash or fever develops ■ irritation, pain or redness persists or worsens ■ symptoms do not improve in 7 days
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 reduce 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 lightheadness • 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 or other "caine" anesthetics
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