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Product NDC Code | 52261-0801 | ||||
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Drug Name | Keeps climax delay |
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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 | LIQUID | ||||
Application Number | M017 | ||||
Labeler Name | Cosco International, Inc. | ||||
Packages |
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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.Uses For temporary male genital desensitization, helping to slow the onset of ejaculation.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alcohol, Benzyl Alcohol, Ethoxydiglycol, Isopropyl Myristate, Panthenol, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Water
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.When using this product avoid contact with eyes.
Purpose
Information about the drug product’s indications for use.Drug Facts Active Ingredient....................Purpose Lidocaine HCL 9.6%..................Male Genital Desensitizer
Spl product data elements
Usually a list of ingredients in a drug product.Keeps Climax Delay Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS LIDOCAINE ALCOHOL BENZYL ALCOHOL DIETHYLENE GLYCOL MONOETHYL ETHER ISOPROPYL MYRISTATE PANTHENOL PHENOXYETHANOL POLYSORBATE 20 .ALPHA.-TOCOPHEROL ACETATE WATER
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.Add image transcription here... Add image transcription here... bottle label carton label
Instructions for use
Information about safe handling and use of the drug product.Directions Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.
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 swallowed, get medical help, or contact a Poison Control Center immedieately.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if you or your partner develop a rash or irritation, such as burning or itching. this product does not provide relief if used as directeed. Premature ejaculation may be due to a condition requiring medical supervision. Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immedieately. Directions Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse. Other information Store at room temperature 68°F to 77°F Inactive ingredients Alcohol, Benzyl Alcohol, Ethoxydiglycol, Isopropyl Myristate, Panthenol, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Water
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature 68°F to 77°F
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 For external use only. When using this product avoid contact with eyes.
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