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| Product NDC Code | 72484-433 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Roman swipes |
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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 | ||||||||||
| Application Number | part348 | ||||||||||
| Labeler Name | Roman Health Ventures 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 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.Inactive ingredients ethyl alcohol (SDA 40B), propylene glycol, purified 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 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.Roman Swipes Benzocaine ALCOHOL WATER 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.roman SWIPES with 4% Benzocaine For longer lasting sex 8 INDIVIDUALLY PACKAGED ENDURANCE WIPES CLINICALLY PROVEN INGREDIENT TO DELAY EJACULATION Swipes_Boxes 12-2021
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
Distributed by Roman Health Ventures, Inc. 116 W. 23rd Street, 4th Floor, New York, NY 10011 888-798-8686 getroman.com
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 symptoms persist.
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 symptoms persist. 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