SKINS DELAY MAXIMUM STRENGTH LIDOCAINE- lidocaine hydrochloride solution

SKINS DELAY Maximum Strength Lidocaine by

Drug Labeling and Warnings

SKINS DELAY Maximum Strength Lidocaine by is a Otc medication manufactured, distributed, or labeled by SKINS SEXUAL HEALTH LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. . 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. Do not exceed 10 sprays

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:

INGREDIENTS AND APPEARANCE

SKINS DELAY MAXIMUM STRENGTH LIDOCAINE 
lidocaine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81923-199
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81923-199-00	1 in 1 BOX	05/25/2021
1		15 mL in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/25/2021

Labeler - SKINS SEXUAL HEALTH LIMITED (221947744)