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#ROMAN SWIPES INGREDIENTS CODE#

This site is not affiliated, endorsed or administered by the Food and Drug Administration (FDA). Reliance on any information provided by the National Drug Codes List website or other visitors to this website is solely at your own risk. The contents of the National Drug Codes List website are provided for educational purposes only and are not intended in any way as medical advice, medical diagnosis or treatment. NDC List 2022 | NDC Data Last Updated: 07-01-2022Īll contents of this website are provided on an "as is" and "as available" basis without warranty of any kind. Inactive ingredients ethyl alcohol (SDA 40B), propylene glycol, purified water

DirectionsApply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor.

If swallowed, get medical help or contact a poison control center right away. 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.

Stop use and ask a doctor ifthis product, used as directed, does not provide relief.When using this product avoid contact with the eyes. UseHelps in temporarily prolonging time until ejaculation Values = "Y", "N", "E", or "I".ĭistributed by Roman Health Ventures, Inc.29 W 30th St. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). This is the date when the listing record will expire if not updated or certified by the product labeler.Įxclude Flag: N - NO What is the NDC Exclude Flag? Listing Expiration Date: 12-31-2023 What is the Listing Expiration Date? This is the date that the labeler indicates was the start of its marketing of the drug product. Start Marketing Date: 01-10-2019 What is the Start Marketing Date?

The complete list of codes and translations can be found at under Structured Product Labeling Resources. Currently, only final marketed product categories are included. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. For unapproved drugs, this field will be null. 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. This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated.

#ROMAN SWIPES INGREDIENTS CODE#

Name of Company corresponding to the labeler code segment of the Product NDC.įDA Application Number: part348 What is the FDA Application Number? Product Labeler Information What is the Labeler Name?

Standardized Chemical Allergen - (Established Pharmacologic Class).

Increased Histamine Release - (Physiologic Effect).

Cell-mediated Immunity - (Physiologic Effect).

These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. Pharmacologic Class(es) What is a Pharmacological Class? The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Topical - Administration to a particular spot on the outer surface of the body.

The translation of the route code submitted by the firm, indicating route of administration. The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.Īdministration Route(s) What are the Administration Route(s)? The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). Inactive Ingredient(s) About the Inactive Ingredient(s) Each ingredient name is the preferred term of the UNII code submitted. Roman Swipes Active Ingredient(s) What is the Active Ingredient(s) List? This data element matches the “Document Type” field of the Structured Product Listing. Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. Product Type: Human Otc Drug What kind of product is this? This dosage form term should not be applied to solutions. The product's dosage form is liquid and is administered via topical form.ĭosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. The generic name of Roman Swipes is benzocaine. Roman Swipes with NDC 72484-433 is a a human over the counter drug product labeled by Roman Health Ventures Inc.