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Product NDC Code | 69681-432 | ||||
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Drug Name | Preboost |
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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 | LIQUID | ||||
RxCUI drug identifier | 1491009 | ||||
Application Number | part348 | ||||
Labeler Name | The Female Health Company d/b/a Veru Healthcare | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzocaine USP 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 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.Inactives Purified water, Ethyl Alcohol (SDA 40B), 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.Use Helps in temporarily prolonging time until 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.Preboost benzocaine benzocaine benzocaine alcohol water propylene glycol
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.PRINCIPAL DISPLAY PANEL - 10 Wipes Packet Box Clinically Proven to Make Sex Last Longer PREBOOST ® KEEP IT GOING 10 Single-Use Wipes Male desensitizing wipes for prolonging the time until ejaculation H Fisch MD Created by Dr. Harry Fisch , Named "One of America's Best Doctors" PRINCIPAL DISPLAY PANEL - 10 Wipes Packet Box
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.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. Avoid contact with the eyes. If you or your partner develops a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
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 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. Avoid contact with the eyes. If you or your partner develops a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor. 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