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| Product NDC Code | 67194-022 | ||||
|---|---|---|---|---|---|
| Drug Name | Microcaine topical analgesic |
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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 | CREAM | ||||
| RxCUI drug identifier | 1534792 | ||||
| Application Number | M015 | ||||
| Labeler Name | Unit Dose, Ltd. | ||||
| 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 Lidocaine 5% w/w Purpose Local Anesthetic
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: Children under 12 years-ask a doctor Adults: Apply 1-2 gm to desired area and wait 12 to 60 minutes. Remove excess. May repeat 2-3 times/day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Water (Aqua), Prolatum Oil. Stearyl Alcohol, Polysorbate 60, Cetearyl Alcohol, Glyceryl Stearate, Carbomer, Triethanolamine, Propylparaben, Propylene Glycol, Methylparaben, Disodium EDTA, Diazolidinyl Carbamide, BHT
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 from anorectal origin.
Purpose
Information about the drug product’s indications for use.Purpose Local Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Microcaine Topical Analgesic LIDOCAINE WATER STEARYL ALCOHOL POLYSORBATE 60 CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE TROLAMINE PROPYLPARABEN PROPYLENE GLYCOL METHYLPARABEN EDETATE DISODIUM BUTYLATED HYDROXYTOLUENE 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.Package Labeling: Mcaine Mcaine2
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
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 swallowed, get medical help right away or contact a Poison Control Center right away. NDC 67194-022-01
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll free 888/452-4946
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 pain worsens or does not improve within 7 days or clears up and appears again in a few days you develop an allergy
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 Do not get into the eyes Do not use more than directed Do not swallow
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 When using this product Do not get into the eyes Do not use more than directed Do not swallow Stop use and ask a doctor if pain worsens or does not improve within 7 days or clears up and appears again in a few days you develop an allergy Keep out of reach of children If swallowed, get medical help right away or contact a Poison Control Center right away. NDC 67194-022-01
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