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| Product NDC Code | 62221-935 | ||||
|---|---|---|---|---|---|
| Drug Name | Sonacaine topical anesthetic with menthol |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1291672, 1291677 |
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| Application Number | M017 | ||||
| Labeler Name | Filltech USA, 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 Lidocaine 4%
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 or older: Apply to affected area not more than 3 to 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine
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 and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Sonacaine Topical Anesthetic With Menthol LIDOCAINE ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CHAMOMILE DIAZOLIDINYL UREA EDETATE DISODIUM GLYCERIN MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER ALCOHOL COMFREY LEAF TROLAMINE LIDOCAINE LIDOCAINE
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.Sonacaine Topical Anesthetic Gel With Menthol 2oz/60g (62221-935-02) Sonacaine
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.Sonacaine Topical Anesthetic Gel With Menthol
Drug Facts
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
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 external use only.
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