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Product NDC Code | 55636-000 | ||||||
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Drug Name | Promescent delay wipes |
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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 | DRESSING | ||||||
Application Number | M017 | ||||||
Labeler Name | Absorption | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Benzocaine 7% 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 a small amount 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 Ingredient Propylene glycol
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.Indications For reducing oversensitivity in the male in advance of intercourse.
Purpose
Information about the drug product’s indications for use.Indications For reducing oversensitivity in the male in advance of intercourse.
Spl product data elements
Usually a list of ingredients in a drug product.Promescent Delay Wipes Benzocaine PROPYLENE GLYCOL 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.Labeling Delay Wipes UC 15 Artwork
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 Keep out of reach of children
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Distributed by: Absorption Pharmaceuticals LLC, Las Vegas, NV 89118, USA. Phone 1-877-852-0106 for reporting serious adverse events associated with use of this product, or visit promescent.com
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Visit Promescent.com
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 Avoid contact with the eyes. Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
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