NDC 54723-006 Dzeus Climax Control Wipes

Benzocaine

NDC Product Code 54723-006

NDC 54723-006-01

Package Description: 3 mL in 1 POUCH

NDC Product Information

Dzeus Climax Control Wipes with NDC 54723-006 is a a human over the counter drug product labeled by Sambria Pharmaceuticals, Llc. The generic name of Dzeus Climax Control Wipes is benzocaine. The product's dosage form is cloth and is administered via topical form.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug What 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.

Dzeus Climax Control Wipes Active Ingredient(s)

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


Administration Route(s)

What 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

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sambria Pharmaceuticals, Llc
Labeler Code: 54723
FDA Application Number: part348 What 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What 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: 12-08-2021 What 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: 12-31-2022 What 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 - NO What 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dzeus Climax Control Wipes Product Label Images

Dzeus Climax Control Wipes 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

Active Ingredient

Benzocaine USP 7%

Purpose

Male genital Sensitizer

Uses

  • Aids in the prevention of premature EjaculationAids in temporarily prolonging the time until ejaculation

Warnings

For External Use onlyDo not use on broken or inflamed skin





If pregnant or breastfeeding, ask a health professional before use





When using this product, avoid contact with eyes





Stop and ask doctor if:





This product, when used as directed, does not provide relief; premature ejaculation may be due to a condition requiring medical supervision





you or your partner develop rash or irritation, such as burning or itching 
symptoms persist

Keep Out Of Reach Of Children

In case of ingestion, seek professional assistance and contact poison control immediately

Directions

Use wipe to apply a small amount of product to the head and shape of the penis before intercourse, or as directed by a doctor. Was off after intercourse





Allow product to dry prior to intercourse





Not suitable for oral use





Use as directed

Other Information

Store between 20°-25 °C (68°-77 °F)

Inactive Ingredients

Lactic Acid, Phenol, Phenoxyethanol, ethylhexylglycerin, Polyethylene Glycol, purified water

* Please review the disclaimer below.