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Numb - Medication Information

Product NDC Code 82429-203
Drug Name

Numb

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine 50 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1534792
Application Number M015
Labeler Name Gabar Health Sciences Corp.
Packages
Package NDC Code Description
82429-203-01 1 tube in 1 carton (82429-203-01) / 38 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Lidocaine 5% W/W

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 toilet tissue or a soft cloth before application of this product. Apply up to 6 times a day. Children un 12 years of age consult a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredient Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purfied Water, Trolamine, Vitamin E Acetate

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 the temporary roliot of local and anorectal discomfort associated with anorectal disorder or inflammation.

Purpose

Information about the drug product’s indications for use.
Purpose Local Anesthetic

Spl product data elements

Usually a list of ingredients in a drug product.
NUMB Lidocaine 5% PROPYLENE GLYCOL HYDROGENATED SOYBEAN LECITHIN TROLAMINE ISOPROPYL MYRISTATE BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE POLYSORBATE 80 .ALPHA.-TOCOPHEROL ACETATE CHOLESTEROL WATER 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.
Principal Primary Panel NUMB CREAM NDC 82429-203-01 Lidocaine Cream 5% NET WT 1.35 OZ (38g) 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.
Other Information • Keep away from direct sunlight or heat. • Store at room temperature 15° to 30°C (59° to 86°F) Questions ? (407) 737-9424

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 the children. In case of accidental ingestion, sook modical attention 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) Do not use this product if Pregnant or breastfeeding, ask a health professional before use. In case of accidental overdose, get medical help or contact Poison Control Center immediately. tamper evident "Do not use this product" If seal is broken or missing. When using this product do not exceed the recommended daily dosage unless directed by doctor. Certain persons can develop allergic reactions to ingredients in this product. Do not put this product into the rectum by using ‑nger or any medical device or applicator. Stop use and ask doctor if the symptoms being treated does not subside, or if redness, Irritation, swelling pain or other symptoms develop or increase.

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