Skins Delay Maximum Strength Lidocaine Solution
FDA Label NDC 81923-199

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skins Sexual Health Limited for the product Skins Delay Maximum Strength Lidocaine (NDC 81923-199). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient (per spray):, purpose:, uses:, warnings:, keep out of reach of children., do not use, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (Per Spray):

Lidocaine HCL 10mg

Purpose:

Anaesthetic

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 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 optimal absorption is reached. Wash hands thoroughly after use. You will feel the product start to work after 3-5 minutes so although you can apply up to 10 sprays we recommend waiting to feel the full effects before applying any more. You should always use minimum effective quantity.

Other Information:

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

Questions?

You can contact Skins on  +44 1636 593943

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.

Package Labeling:

Label3 (Label3)

Label3 (Label3)

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