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| Product NDC Code | 0496-0883 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Lmx5 |
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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 | 1366789, 1422107 |
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| Application Number | part346 | ||||||||
| Labeler Name | Ferndale Laboratories, Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and Children 12 years and older: Apply to the affected area up to 6 times a day. Children under 12 years of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients benzyl alcohol, carbomer 940, chloesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and 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 temporarily relieves pain and itching due to anorectal disorders
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.LMX5 lidocaine BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE C CHOLESTEROL LECITHIN, SOYBEAN ISOPROPYL MYRISTATE POLYSORBATE 80 PROPYLENE GLYCOL WATER TROLAMINE ALPHA-TOCOPHEROL ACETATE 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 Manufactured for Ferndale Healthcare Inc. Ferndale, MI 48220 U.S.A. Toll free (888) 548-0900 www.ferndalehealthcare.com L.M.X.5® is a registered trademark of Ferndale, IP Inc. 30 gram NDC 0496-0883-30 Carton
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 rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs redness, irritation, swelling, pain or other symptoms begin or increase symptoms clear up and return 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 avoid contact with eyes do not exceed recommended dosage unless directed by a doctor
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
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 When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs redness, irritation, swelling, pain or other symptoms begin or increase symptoms clear up and return within a few days Keep out of reach of children. 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