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Product NDC Code | 82191-001 | ||||
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Drug Name | Steady freddy |
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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 | SPRAY | ||||
Application Number | M017 | ||||
Labeler Name | Medical Symbiosis Pty Ltd | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Lidocaine 9.6% w/ 10mg (Per Spray)
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 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients
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 temporarily prolonging the time until ejaculation.
Purpose
Information about the drug product’s indications for use.Purpose Topical Anesthetic- Male Genital Desensitizer
Spl product data elements
Usually a list of ingredients in a drug product.Steady Freddy Lidocaine WATER PEG-40 STEARATE SACCHARIN SODIUM ALCOHOL ISOPROPYL MYRISTATE MEDIUM-CHAIN TRIGLYCERIDES LIDOCAINE LIDOCAINE
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.Steady Freddy
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 Keep Out of Reach of Children. If swallowed, get medical help.
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
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