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| Product NDC Code | 56152-1470 | ||||
|---|---|---|---|---|---|
| Drug Name | Pleasure balm kama sutra |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M017 | ||||
| Labeler Name | Cosmetic Enterprises Ltd | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Benzocaine 5.0 % Male genital desensitizer Use Helps in temporarily prolonging time until ejaculation Keep out of reach of children. Discontinue use and consult a doctor if This product, used as directed does not provide relief You or your partner develops a rash or irritation, such as burning or itching Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder which may appear up to 2 hours of use Warnings DO NOT use if allergic to Benzocaine or any other ingredient in this product If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away. Premature ejaculation may be due to condition requiring medical supervision Consult a doctor prior to use if partner is pregnant Avoid contact with eyes: if this happens, rinse thoroughly with water Known adverse reactions Hypersensitivity/allergy has been known to occur, in such a case, discontinue use. Directions for use Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only. Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)
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 for use Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only. Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)
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.Discontinue use and consult a doctor if This product, used as directed does not provide relief You or your partner develops a rash or irritation, such as burning or itching Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder which may appear up to 2 hours of use Warnings DO NOT use if allergic to Benzocaine or any other ingredient in this product If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away. Premature ejaculation may be due to condition requiring medical supervision Consult a doctor prior to use if partner is pregnant Avoid contact with eyes: if this happens, rinse thoroughly with water Known adverse reactions Hypersensitivity/allergy has been known to occur, in such a case, discontinue use. Directions for use Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only. Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)
Purpose
Information about the drug product’s indications for use.Use Helps in temporarily prolonging time until ejaculation Keep out of reach of children. Discontinue use and consult a doctor if This product, used as directed does not provide relief You or your partner develops a rash or irritation, such as burning or itching Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder which may appear up to 2 hours of use Warnings DO NOT use if allergic to Benzocaine or any other ingredient in this product If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away. Premature ejaculation may be due to condition requiring medical supervision Consult a doctor prior to use if partner is pregnant Avoid contact with eyes: if this happens, rinse thoroughly with water Known adverse reactions Hypersensitivity/allergy has been known to occur, in such a case, discontinue use. Directions for use Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only. Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)
Spl product data elements
Usually a list of ingredients in a drug product.Pleasure Balm Kama Sutra Benzocaine FD&C BLUE NO. 1 EDETATE DISODIUM CETYL HYDROXYETHYLCELLULOSE (350000 MW) MENTHA PIPERITA POLYETHYLENE GLYCOL 400 POLYSORBATE 60 PROPYLENE GLYCOL SACCHARIN SODIUM WATER FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 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.Pleasure Balm Prolonging Gel for Men Male Genital Desensitizer Desensibilisateur Genital Pour hommes 0.4 fl oz 12 ml Box
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. Discontinue use and consult a doctor if This product, used as directed does not provide relief You or your partner develops a rash or irritation, such as burning or itching Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder which may appear up to 2 hours of use Warnings DO NOT use if allergic to Benzocaine or any other ingredient in this product If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away. Premature ejaculation may be due to condition requiring medical supervision Consult a doctor prior to use if partner is pregnant Avoid contact with eyes: if this happens, rinse thoroughly with water Known adverse reactions Hypersensitivity/allergy has been known to occur, in such a case, discontinue use. Directions for use Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only. Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)
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 DO NOT use if allergic to Benzocaine or any other ingredient in this product If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away. Premature ejaculation may be due to condition requiring medical supervision Consult a doctor prior to use if partner is pregnant Avoid contact with eyes: if this happens, rinse thoroughly with water Known adverse reactions Hypersensitivity/allergy has been known to occur, in such a case, discontinue use. Directions for use Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only. Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)
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