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Smart numb lidocaine cream - Medication Information

Product NDC Code 76092-201
Drug Name

Smart numb lidocaine cream

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine 5 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1366789
Application Number M015
Labeler Name M.J. Winston International, Ltd.
Packages
Package NDC Code Description
76092-201-02 57 g in 1 jar (76092-201-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Lidocaine 5% local anesthetic active

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.
dosage administration

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Aacrylates, Allantoin, Arnice Montana Flower Extract, Deionized Water, Dimethyl Isosorbide, Emu Oil, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polydecene, Menthol, Phenoxythanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium Edta, Tocopheryl Acetate, Trideceth-6 inactive

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, burning, and soreness associated with anorectal discomfort or inflammation. indication

Purpose

Information about the drug product’s indications for use.
Use For the temporary relief of pain, burning, and soreness associted with anorectal discomfort or inflammation. use

Spl product data elements

Usually a list of ingredients in a drug product.
SMART Numb Lidocaine Cream lidocaine PROPYLENE GLYCOL ARNICA MONTANA FLOWER MENTHOL TRIDECETH-6 ETHYLHEXYLGLYCERIN PHENOXYETHANOL SUNFLOWER OIL EDETATE SODIUM SODIUM POLYACRYLATE (2500000 MW) HYDROGENATED POLYDECENE (1500 CST) WATER DIMETHYL ISOSORBIDE EMU OIL ALLANTOIN .ALPHA.-TOCOPHEROL ACETATE, D- ETHYLHEXYL PALMITATE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) 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 label principal

Instructions for use

Information about safe handling and use of the drug product.
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. For products for external use only. Apply up to 6 times a day. Children under 12 years of age: consult a doctor. directions

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

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information Store at 59F to 86F (15C to 30C). Keep away from direct sunlight. other info

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or concerns? Contact [email protected] or 714-582-2715. questions

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 excceed recommended dosage unless directed by a doctor. when using this product

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. Stop use and ask a doctor if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop. If pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Keep out of reach of children. 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

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