NDC 65112-265 Wakaya Ruru Topical Analgesic

External Analgesic

NDC Product Code 65112-265

NDC 65112-265-01

Package Description: 71 g in 1 BOTTLE, PUMP

NDC Product Information

Wakaya Ruru Topical Analgesic with NDC 65112-265 is a a human over the counter drug product labeled by I Shay Cosmetics Inc. The generic name of Wakaya Ruru Topical Analgesic is external analgesic. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 416982.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Wakaya Ruru Topical Analgesic 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: I Shay Cosmetics Inc
Labeler Code: 65112
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: 01-13-2021 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".

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Wakaya Ruru Topical Analgesic Product Label Images

Wakaya Ruru Topical Analgesic 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

Otc - Active Ingredient

Benzocaine 5% .... Male Genital Desensitizer

Otc - Purpose

Male Genital Desensitizer

Otc - Keep Out Of Reach Of Children

WARNINGS - Keep out of reach of children

Indications & Usage

For temporary male genital desensitization, helping to slow the onset of ejaculation.

Inactive Ingredient

Deionized Water, Propylene Glycol, Coconut Oil, Stearic Acid, Isopropyl Palmitate, Capric/Caprylic Triglyceride, Soya Oil, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20 Glycol Stearate, Dimethicone 100, PEG-100, Sodium Hydroxide, Carbomer, Phenoxyethanol, Propylparaben, Methylparaben, Fragrance.

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 physician.Keep out of reach of children.If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor. Avoid contact with the eyes.

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.

* Please review the disclaimer below.