Lidocaine HCL 4 g/100g
Lidocaine HCL · CREAM · Matthias Therapeutics, LLC
Lidocaine HCL is a cream containing lidocaine hcl at 4 g/100g, taken topical. Manufactured by Matthias Therapeutics, LLC.
Key Facts
- Brand Name
- Lidocaine HCL
- Generic Name
- Lidocaine HCL
- NDC Code (Product)
87137-101- Manufacturer
- Matthias Therapeutics, LLC
- Strength
- 4 g/100g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- M017
- Marketing Start
- 03/12/2026
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Spectra Medical Devices, Llc
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Tri-Coast Pharmacy
Lack of Assurance of Sterility
RXQ Compounding LLC
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Lack of Assurance of Sterility
Indelicare LLC
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS: Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Apply product to the affected area(s) twice daily or as directed by a physician. Product should not be used in excess of recommendations or for prolonged use in the anal canal. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician. Products without Applicators: Remove the child-resistant cap and foil seal from the tube. Apply a thin film to the affected area. Replace the cap after use. Products with Single-Use Tubes and Applicators: Tear open one cleansing wipe packet (if the product kit contains such item), gently clean the affected area and discard the used cleansing wipe. Remove the child-resistant cap and foil seal from one tube and firmly screw one applicator onto the tube. Do not over tighten. Squeeze the tube to fill the applicator until a small amount of cream/gel comes out of and lubricates the applicator openings. Gently insert the applicator tip with attached tube into anal area. Continue squeezing the body of the tube as it is moved around the areas of discomfort, and lastly, around and in the anal opening (if directed by physician). Do not completely insert the…
Warnings
PRECAUTIONS: For external use only. Not for ophthalmic use. Product and used applicators could harm small children if chewed or swallowed. Keep out of reach of children. Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin. Product should not be ingested or applied into the mouth, inside of the nose or in the eyes. Product should not be used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicted because of ototoxicty associated with lidocaine observed in animals when instilled in the middle ear. Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion. If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.
Contraindications
CONTRAINDICATIONS: Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. Product should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. Product is contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
ADVERSE REACTIONS: During or immediately following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin.
Frequently Asked Questions
What is Lidocaine HCL used for?
Lidocaine HCL contains Lidocaine HCL. It is a cream taken topical. Consult your doctor for specific uses.
Is Lidocaine HCL a controlled substance?
Lidocaine HCL is not classified as a controlled substance by the DEA.
What is the generic name for Lidocaine HCL?
The generic name for Lidocaine HCL is Lidocaine HCL. There are 11 other brand versions of Lidocaine HCL.
What is the NDC code for Lidocaine HCL 4 g/100g?
The NDC (National Drug Code) for Lidocaine HCL 4 g/100g is 87137-101, listed by Matthias Therapeutics, LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)