Drugplain

Lidocort 5 mg/g

LIDOCAINE HCL - HYDROCORTISONE ACETATE · CREAM · PureTek Corporation

No Recall HistoryCurrently in Shortage
Plain English

Lidocort is a cream containing lidocaine hcl - hydrocortisone acetate at 5 mg/g, taken rectal. Manufactured by PureTek Corporation.

Key Facts

Brand Name
Lidocort
Generic Name
LIDOCAINE HCL - HYDROCORTISONE ACETATE
NDC Code (Product)
59088-430
Manufacturer
PureTek Corporation
Strength
5 mg/g
Dosage Form
CREAM
Route
RECTAL, TOPICAL
Marketing Status
Marketing Start
09/01/2020

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS: For the temporary relief of pain and itching associated with minor burns, sunburns, minor skin irritations or hemmorhoids and itching associated with inflammation, and rashes due to eczema.

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 used in the anal canal. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advise 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 th

Warnings

WARNINGS: 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 of skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any 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 Lidocort used for?

Lidocort contains LIDOCAINE HCL - HYDROCORTISONE ACETATE. It is a cream taken rectal. Consult your doctor for specific uses.

Is Lidocort a controlled substance?

Lidocort is not classified as a controlled substance by the DEA.

What is the generic name for Lidocort?

The generic name for Lidocort is LIDOCAINE HCL - HYDROCORTISONE ACETATE. There are 1 other brand versions of LIDOCAINE HCL - HYDROCORTISONE ACETATE.

What is the NDC code for Lidocort 5 mg/g?

The NDC (National Drug Code) for Lidocort 5 mg/g is 59088-430, listed by PureTek Corporation.

Product NDC

59088-430

Package NDC

59088-430-05

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)