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Advanced numb topical anesthetic - Medication Information

Product NDC Code 71131-052
Drug Name

Advanced numb topical anesthetic

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride 50 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1491882
Application Number M015
Labeler Name Uber Scientific, LLC
Packages
Package NDC Code Description
71131-052-04 114 g in 1 jar (71131-052-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Lidocaine HCL (5%) Purpose External Analgesic

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 and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product. Apply externally up to 6 times per day. Children under 12: Consult a Doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Allantoin Gel, Deionized Water, Benzyl Alcohol, Carbomer, Pro-pylene GLycol, Sodim Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine

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.
Use For the temporary relief of pain and discomfort associated with anorectal disorders.

Purpose

Information about the drug product’s indications for use.
Purpose External Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
ADVANCED NUMB Topical Anesthetic LIDOCAINE HYDROCHLORIDE WATER BENZYL ALCOHOL CARBOXYPOLYMETHYLENE PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL TROLAMINE LIDOCAINE HYDROCHLORIDE 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: Jar

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.
Other Information Store at room temperature. Avoid Direct sunlight.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, Consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

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 the Poison Control Center 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. If condition worsens or does not improve within 7 days, consult a doctor. Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, Consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center immediately.

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