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Product NDC Code | 54723-006 | ||||
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Drug Name | Dzeus climax control wipes |
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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 | CLOTH | ||||
Application Number | M017 | ||||
Labeler Name | Sambria Pharmaceuticals, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzocaine USP 7%
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 Use wipe to apply a small amount of product to the head and shape of the penis before intercourse, or as directed by a doctor. Wash off after intercourse. Allow product to dry prior to intercourse. Not suitable for oral use. Use as directed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Lactic Acid, Phenol, Phenoxyethanol, ethylhexylglycerin, Polyethylene Glycol, purified 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.Uses Aids in the prevention of premature ejaculation Aids in temporarily prolonging the time until 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.DZEUS Climax control wipes Benzocaine WATER LACTIC ACID, UNSPECIFIED FORM PHENOL PHENOXYETHANOL ETHYLHEXYLGLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED 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.Product label image description
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 between 20°-25 °C (68°-77 °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 In case of ingestion, seek professional assistance and contact poison control immediately.
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. Do not use on broken or inflamed skin. If pregnant or breastfeeding , ask a health professional before use. When using this product, avoid contact with eyes. Stop and ask doctor if : This product, when used as directed, does not provide relief; premature ejaculation may be due to a condition requiring medical supervision,you or your partner develop rash or irritation, such as burning or itching symptoms persist.
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