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Intimale benzocaine delay gel - Medication Information

Product NDC Code 81923-369
Drug Name

Intimale benzocaine delay gel

Type Brand
Pharm Class Allergens [CS],
Cell-mediated Immunity [PE],
Increased Histamine Release [PE],
Standardized Chemical Allergen [EPC]
Active Ingredients
Benzocaine 50 mg/ml
Route TOPICAL
Dosage Form GEL
Application Number M017
Labeler Name SKINS SEXUAL HEALTH LIMITED
Packages
Package NDC Code Description
81923-369-00 15 ml in 1 bottle (81923-369-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT: Benzocaine 5.00% 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 3-5 pumps 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 absorbedOther Information:. You should always use the minimum effective quantity.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: Aqua (deionized Water), Ethylhexylglycerin, Hydroxyethylcellulose, l-Arginine, Lepidium Meyenii (Maca) Extract, Panax Ginseng Root Extract, PEG-8, Phenoxyethanol, Propylene Glycol.

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.
INTIMALE Benzocaine Delay Gel BENZOCAINE ALOE VERA LEAF ETHYLHEXYLGLYCERIN HYDROXYETHYL CELLULOSE, UNSPECIFIED ARGININE ASIAN GINSENG POLYETHYLENE GLYCOL 400 PHENOXYETHANOL PROPYLENE GLYCOL BENZOCAINE BENZOCAINE

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: Bottle8

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 below 30°C (86°F).

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? You can contact us 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.

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