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Lidocore - Medication Information

Product NDC Code 82944-201
Drug Name

Lidocore

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride anhydrous 3.1 g/76.5g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1010895
Application Number M017
Labeler Name iON Pharma, LLC
Packages
Package NDC Code Description
82944-201-02 1 bottle in 1 carton (82944-201-02) / 76.5 g in 1 bottle
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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 section Directions: Adults, or children over the age of 12, apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. Children 12 years and younger ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl Propanol, Cetearyl Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate, Cyclopentasiloxane (and) Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, SD Alcohol, Steareth-21, 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.
Uses Uses: For temporary relief of pain.

Purpose

Information about the drug product’s indications for use.
drug facts Active ingredients Drug Facts Active ingredients: Purpose Lidocaine HCI 4% Topical anesthetic

Spl product data elements

Usually a list of ingredients in a drug product.
Lidocore Lidocaine GLYCERYL 1-STEARATE ETHYLHEXYLGLYCERIN STEARETH-21 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) DIMETHICONE 350 DIHEXADECYL PHOSPHATE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) LIDOCAINE HYDROCHLORIDE ANHYDROUS LIDOCAINE ALCOHOL 95% ALOE VERA LEAF PHENOXYETHANOL CYCLOMETHICONE 5 HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) EDETATE DISODIUM ANHYDROUS WATER AMINOMETHYLPROPANOL CETETH-10 PHOSPHATE ISOHEXADECANE CETOSTEARYL ALCOHOL

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.
Panel

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 and pets section Keep out of reach of children and pets. 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 section Questions or Comments? Call 833.711.8833 , [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 use section Stop use and consult a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few 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 section When using this product use only as directed. Read and follow all directions and warnings on this carton. Do not allow contact with the eyes, do not bandage or apply local heat (such as heating pads) to the area of use

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breastfeeding section If 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.
Do not use section Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds for more than one week without consulting a doctor

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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