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Product NDC Code | 81923-364 | ||||
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Drug Name | Skins delay climax control lidocaine |
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Type | Brand | ||||
Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOLUTION | ||||
Application Number | M017 | ||||
Labeler Name | SKINS SEXUAL HEALTH LIMITED | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (per spray): Lidocaine HCL 10mg Purpose: Male Genital Desensitizer
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS: Apply 3 or more sprays to the head and shaft of the penis before sexual activity, or as directed by your doctor. Massage the product onto the penis until fully absorbed DO NOT exceed 10 sprays. You should always use the minimum effective quantity
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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, Phenoxyethanol, Polysorbate 20, Serenoa Serrulata (Saw Palmetto) Extract, l-Carnitine, Tocopheryl Acetate (Vitamin E), Tribulus Terrestris Extract, Zemea (Corn) Propanediol.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES: Helps to temporarily prevent premature ejaculation.
Purpose
Information about the drug product’s indications for use.Purpose: Male Genital Desensitizer
Spl product data elements
Usually a list of ingredients in a drug product.SKINS DELAY Climax Control Lidocaine LIDOCAINE HYDROCHLORIDE ALOE VERA LEAF WATER ARGININE ASCORBIC ACID CHAMOMILE ETHYLHEXYLGLYCERIN FOLIC ACID GLYCERIN GLYCYRRHIZA GLABRA HYDROXYETHYL CELLULOSE, UNSPECIFIED HYPERICUM PERFORATUM WHOLE LEPIDIUM MEYENII ROOT NIACIN ASIAN GINSENG PHENOXYETHANOL POLYSORBATE 20 SAW PALMETTO LEVOCARNITINE .ALPHA.-TOCOPHEROL ACETATE TRIBULUS TERRESTRIS WHOLE CORN LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Labeling: Bottle
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Other Information: Store in a cool dry place out of direct sunlight. Store below 30°C (86°F).
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • on broken or inflamed skin, if partner is pregnant, on large areas of the body, or orally.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. • If product is swallowed, get medical attention or contact poison control center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? Contact Skins on +44 1636 593943
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. • • • If you or your partner develop a rash or irritation, such as burning or itching, discontinue use and consult a physician. FOR EXTERNAL USE ONLY. Avoid contact with eyes. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API