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Product NDC Code | 72854-683 | ||||
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Drug Name | Ky duration for him |
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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 | part348 | ||||
Labeler Name | RB Health (US) 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 apply a small amount to the head and shaft of the penis before intercourse, or use as directed by a doctor. Wash product off after intercourse. use only on intact, non-inflamed skin allow gel to dry prior to intercourse not suitable for oral use use as directed, not more than four times per day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients carbomer homopolymer type B, polyethylene 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 in the prevention of premature ejaculation helps 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.KY Duration for Him Benzocaine Benzocaine Benzocaine CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) POLYETHYLENE GLYCOL, UNSPECIFIED
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.PRINCIPAL DISPLAY PANEL 5.0 mL Can Label 36 pumps KY ® EST 1904 duration ® gel for him male genital desensitizer Benzocaine USP 7% latex condom compatible don't stop 36 Pumps 0.16 fl oz (5.0 mL) PRINCIPAL DISPLAY PANEL 5.0 mL Can Label
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
Dist. by: RB Health (US) Parsippany, NJ 07054-0224
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 right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-756-5488
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20-25°C (68-77°F) compatible with latex condoms child resistant closure. Instructions for opening are included in the leaflet. read the enclosed leaflet to achieve best results
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 Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor. Avoid contact with the eyes If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor. If pregnant or breastfeeding, ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact a poison Control Center right away.
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