NDC 72484-433 Roman Swipes

Benzocaine

NDC Product Code 72484-433

NDC Code: 72484-433

Proprietary Name: Roman Swipes Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzocaine Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 72484 - Roman Health Ventures Inc.
    • 72484-433 - Roman Swipes

NDC 72484-433-03

Package Description: 3 PACKET in 1 BOX > 1.2 mL in 1 PACKET

NDC 72484-433-08

Package Description: 8 PACKET in 1 BOX > 1.2 mL in 1 PACKET

NDC Product Information

Roman Swipes with NDC 72484-433 is a a human over the counter drug product labeled by Roman Health Ventures Inc.. The generic name of Roman Swipes is benzocaine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Roman Health Ventures Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Roman Swipes Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZOCAINE 4 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Roman Health Ventures Inc.
Labeler Code: 72484
FDA Application Number: part348 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-10-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Roman Swipes Product Label Images

Roman Swipes Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Distributed by Roman Health Ventures, Inc.29 W 30th St. New York, NY 10001888-798-8686

Otc - Active Ingredient

Active ingredientBenzocaine USP 4%

Otc - Purpose

PurposeMale Genital Desensitizer

Indications & Usage

UseHelps in temporarily prolonging time until ejaculation

Warnings

WarningsFor external use only

Otc - When Using

When using this product avoid contact with the eyes.

Otc - Stop Use

  • Stop use and ask a doctor ifthis 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 itchingsymptoms persist.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Dosage & Administration

  • DirectionsApply 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

Inactive ingredients ethyl alcohol (SDA 40B), propylene glycol, purified water

* Please review the disclaimer below.

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