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| Product NDC Code | 70907-098 | ||||
|---|---|---|---|---|---|
| Drug Name | Numb plus maximum strength anorectal |
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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 | GEL | ||||
| Application Number | M015 | ||||
| Labeler Name | SEENEXT VENTURE 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 Ingredient Lidocaine 5.00% Purpose Anorectal (Hermorrhoidal)
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 Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product when first opening the jar, twist the cap and peel off the foil seal apply externally to the affected area up to 6 times daily children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Dodecane, Ethylhexylglycerin, Lecithin, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol
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 For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders
Purpose
Information about the drug product’s indications for use.Purpose Anorectal (Hermorrhoidal)
Spl product data elements
Usually a list of ingredients in a drug product.NUMB PLUS Maximum Strength Anorectal LIDOCAINE ALLANTOIN ALOE VERA LEAF WATER BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE DIMETHYL ISOSORBIDE DODECANE ETHYLHEXYLGLYCERIN PHENOXYETHANOL PROPYLENE GLYCOL EDETATE SODIUM .ALPHA.-TOCOPHEROL TROLAMINE CORN PROPANEDIOL 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.Package Labeling: 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
Other Information always keep the jar tightly closed protect from freezing store at room temperatures not exceeding 59°F to 86°F (15°C to 30°C)
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 or comments? Call weekdays 9AM to 6PM PST at 1-844-700-6862 or email us at [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop the use and consult doctor if allergic reaction occurs rectal bleeding occurs redness, irritation, swelling, pain, or other symptoms begin or increase condition worsens or does not improve within 7 days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use
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 When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop the use and consult doctor if allergic reaction occurs rectal bleeding occurs redness, irritation, swelling, pain, or other symptoms begin or increase condition worsens or does not improve within 7 days KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away If pregnant or breastfeeding, ask a health professional before use
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