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| Product NDC Code | 69006-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Prolayed |
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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 | OINTMENT | ||||
| Application Number | M004 | ||||
| Labeler Name | ViaDerma, Inc | ||||
| 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 spray) Lidocaine 10 mg Purpose Male genital desensitizer
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 Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxyethylcellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, stearic acid, water
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 Helps in temporarily slowing the onset of ejaculation.
Purpose
Information about the drug product’s indications for use.Purpose Male genital desensitizer
Spl product data elements
Usually a list of ingredients in a drug product.Prolayed LIDOCAINE ACETIC ACID ASCORBIC ACID CHLORHEXIDINE GLUCONATE CHOLECALCIFEROL DIMETHYL SULFOXIDE DIPROPYLENE GLYCOL GLUCONOLACTONE GLYCERIN HISTIDINE MAGNESIUM STEARATE METHYLPARABEN SODIUM HYDROXIDE SORBIC ACID STEARIC ACID WATER 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: Label
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 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 doctor if this product, used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision you or your partner develop a rash or irritation, such as burning or itching.
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 the 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 external use only When using this product avoid contact with the eyes. Stop use and ask a doctor if this product, used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision you or your partner develop a rash or irritation, such as burning or itching. Keep out of reach of children. If 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