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| Product NDC Code | 54723-007 | ||||
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| Drug Name | Ombre men overtime 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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| Check if available Online | Get Medication Prices online with Discount |
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 head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse. Not suitable for oral use. Use as directed, not for use more than four times per day.
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.Indication For reducing oversensitivity in the male in advance of intercourse,
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.Ombre Men overtime 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
For Questions or Comments, visit our website OMBREMEN.COM
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.
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 irritated skin. When using this avoid contact with eyes. Stop and ask doctor if : the product, 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