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| Product NDC Code | 0496-0882 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Lmx4 |
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| Type | Brand | ||||||||||||||
| 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 | CREAM | ||||||||||||||
| RxCUI drug identifier | 1421893, 1422103 |
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| Application Number | part348 | ||||||||||||||
| Labeler Name | Ferndale Laboratories, Inc. | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine 4% 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 and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day Children under 2 years: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, trolamine, vitamin E acetate, 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 temporarily relieves pain and itching due to minor cuts minor scrapes minor burns sunburn minor skin irritations insect bites
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.LMX4 lidocaine BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE C CHOLESTEROL POLYSORBATE 80 PROPYLENE GLYCOL TROLAMINE ALPHA-TOCOPHEROL ACETATE 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.Package Labels-Principal Display Panels Manufactured by Ferndale Laboratories, Inc. Ferndale, MI 48220 U.S.A. Toll free (888) 548-0900 www.ferndalelabs.com L.M.X.4® is a registered trademark of Ferndale IP, Inc. Tegaderm™ is a trademark of 3M Corporation. NDC 0496-0882-06 L.M.X.4® 5 x 5 grams NDC 0496-0882-07 L.M.X.4® 5 x 5 grams with 10 3M Tegaderm™ Transparent Dressings NDC 0496-0882-15 L.M.X.4® 15 grams NDC 0496-0882-30 L.M.X.4® 30 grams NDC 0496-0882-71 L.M.X.4® 30 grams with 10 3M Tegaderm™ Transparent Dressings NDC 0496-0882-05 L.M.X.4 5 grams 5x5gcarton 5x5gwtegadermcarton 15gcarton 30g 30gwtegadermcarton 5g
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 use in or near the eyes in large quantities, particularly over raw surfaces or blistered areas
Instructions for use
Information about safe handling and use of the drug product.Other Information May be applied under occlusive dressing. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
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 a Poison Control Center right away.
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 and ask a doctor if: allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase
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 in or near the eyes in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if: allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin 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