Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream
Lidocaine HCl and Hydrocortisone Acetate · KIT · PureTek Corporation
Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream is a kit containing lidocaine hcl and hydrocortisone acetate, taken rectal. Manufactured by PureTek Corporation.
Key Facts
- Brand Name
- Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream
- Generic Name
- Lidocaine HCl and Hydrocortisone Acetate
- NDC Code (Product)
59088-721- Manufacturer
- PureTek Corporation
- Dosage Form
- KIT
- Route
- RECTAL
- Marketing Status
- Marketing Start
- 06/30/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS: Indicated 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 licensed healthcare practitioner. 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 licensed healthcare practitioner. Use under the direction of a licensed healthcare practitioner. 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 overtighten. Squeeze the tube to fill the applicator until a small amount of cream 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 discom…
Warnings
WARNINGS: For external use only. Not for ophthalmic use. Product and used applicators could harm small children if chewed or swallowed. KEEP THIS AND ALL MEDICATIONS OUT OF THE 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 3% and Hydrocortisone Acetate 0.5% Cream used for?
Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream contains Lidocaine HCl and Hydrocortisone Acetate. It is a kit taken rectal. Consult your doctor for specific uses.
Is Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream a controlled substance?
Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream is not classified as a controlled substance by the DEA.
What is the generic name for Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream?
The generic name for Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream is Lidocaine HCl and Hydrocortisone Acetate. There are 6 other brand versions of Lidocaine HCl and Hydrocortisone Acetate.
What is the NDC code for Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream ?
The NDC (National Drug Code) for Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream is 59088-721, listed by PureTek Corporation.
Other Lidocaine Brands
See all →- Lidocaine HCl - Hydrocortisone Acetate20 mg/g59088-816
- Lidocaine HCl 3% and Hydrocortisone Acetate1% Cream59088-700
- Lidocaine HCl - Hydrocortisone Acetate25 mg/g59088-838
- Lidocaine HCl - Hydrocortisone Acetate5 mg/g59088-819
- Lidocaine HCl - Hydrocortisone Acetate with Aloe5.5 mg/g59088-817
- Lidocaine HCl - Hydrocortisone Acetate10 mg/g59088-771
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)