NDC 81923-197 Intimale Maximum Strength Delay

Lidocaine Hydrochloride

NDC Product Code 81923-197

NDC 81923-197-00

Package Description: 1 CYLINDER in 1 BOX > 15 mL in 1 CYLINDER

NDC Product Information

Intimale Maximum Strength Delay with NDC 81923-197 is a a human over the counter drug product labeled by Skins Sexual Health Limited. The generic name of Intimale Maximum Strength Delay is lidocaine hydrochloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Skins Sexual Health Limited

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Intimale Maximum Strength Delay 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.

  • LIDOCAINE HYDROCHLORIDE 10 mg/mL

Inactive Ingredient(s)

About 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARGININE (UNII: 94ZLA3W45F)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CHAMOMILE (UNII: FGL3685T2X)
  • EPIMEDIUM GRANDIFLORUM TOP (UNII: 137PC46F89)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • FOLIC ACID (UNII: 935E97BOY8)
  • GINKGO (UNII: 19FUJ2C58T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB)
  • LEPIDIUM MEYENII ROOT (UNII: HP7119212T)
  • NIACIN (UNII: 2679MF687A)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SAW PALMETTO (UNII: J7WWH9M8QS)
  • LEVOCARNITINE (UNII: 0G389FZZ9M)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIBULUS TERRESTRIS WHOLE (UNII: 4X4HLN92OT)
  • CORN (UNII: 0N8672707O)

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: Skins Sexual Health Limited
Labeler Code: 81923
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: 05-25-2021 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.

Intimale Maximum Strength Delay Product Label Images

Intimale Maximum Strength Delay 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 (Per Spray):

Lidocaine HCL 10mg

Purpose:

Anesthetic

Uses:

Helps to temporarily prevent premature ejaculation.

Warnings:

  • Premature ejaculation may be due to a condition requiring medical supervision. If this product, when used as directed, does not provide relief, discontinue use and consult a physician.For external use only.Avoid contact with eyes. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use and consult a physician.

Keep Out Of Reach Of Children.

  • If product is swallowed, get medical attention or contact poison control center immediately.

Do Not Use

  • On broken or inflamed skin, if partner is pregnant, on large areas of the body, or orally.

Directions:

Apply 3-5 minutes prior to intercourse. Shake gently before use. Apply 3 or more sprays to the head and shaft of the penis depending on the level of anaesthesia desired. 


DO NOT exceed


10 sprays. Massage into the penis for around twenty seconds or until product is completely


absorption is reached. Wash hands thoroughly after use. You will feel the product start to work after 3-5 minutes. If you do not experience the desired effect after the product has completely absorbed into the skin, gradually increase the dosage until the desired effect has been achieved. You should always use minimum effective quantity.

Other Information:

Store in a cool dry place out of direct sunlight below 30°c (86°F)• Do not use if seal under cap is broken or missing.

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), l-Arginine, Ascorbic Acid (Vitamin C), Chamomilla Recutita (Chamomile) Extract, Epimedium (Horny Goat) Weed Extract, Ethylhexylglycerin, Folic Acid (Vitamin B9), Ginko Biloba Extract, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxyethylcellulose, Hypericum Perforatum (St John’s) Extract, Lepidium Meyenii (Maca) Root Extract, Niacin, Panax Ginseng Root Extract, Parfum (Fragrance), Phenoxyethanol, Polysorbate 20, Serenoa Serrulata (Saw Palmetto) Extract, l-Carnitine, Tocopheryl Acetate (Vitamin E), Tribulus Terrestris Extract, Zemea (Corn) Propanediol.

Questions?

You can contact us on


+44 1636 593943

* Please review the disclaimer below.