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Product NDC Code | 63868-451 | ||||
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Drug Name | Lidocaine hcl 4% |
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Type | Generic | ||||
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 | OINTMENT | ||||
Application Number | part348 | ||||
Labeler Name | CHAIN DRUG MARKETING ASSOCIATION INC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Lidocaine HCl 4%
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.Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period. BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER. Children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, triethanolamine, vitamin E
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.temporary relieves minor joint and muscle pain
Purpose
Information about the drug product’s indications for use.Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine HCl 4% Lidocaine HCl 4% .ALPHA.-TOCOPHEROL ACETATE, DL- WATER POLYSORBATE 80 LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS LECITHIN, SOYBEAN BENZYL ALCOHOL CARBOMER 940 PROPYLENE GLYCOL TROLAMINE
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.1
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. If swallowed, get medical help or contact a Poison Control Center right away.
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.For external use only 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. 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. Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
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