Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Each carton, NDC 24470-965-20, contains 20 single-use ¼ oz (7 g) tubes of Lidocaine 3% - Hydrocortisone 0.5% Cream, 20 applicators, and 20 moist wipes. Each tube is a unit of use - not for individual sale. Discard tube, applicator, and wipe after use. To report a serious adverse event or obtain product information, call 1-855-899-4237. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence. Manufactured for: Cintex Services, LLC 9330 LBJ Freeway, Suite 900 Dallas, TX 75243 2400227 [00] Rev. 09/2024; carton
- HOW SUPPLIED: Each carton, NDC 24470-965-20, contains 20 single-use ¼ oz (7 g) tubes of Lidocaine 3% - Hydrocortisone 0.5% Cream, 20 applicators, and 20 moist wipes. Each tube is a unit of use - not for individual sale. Discard tube, applicator, and wipe after use. To report a serious adverse event or obtain product information, call 1-855-899-4237. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence. Manufactured for: Cintex Services, LLC 9330 LBJ Freeway, Suite 900 Dallas, TX 75243 2400227 [00] Rev. 09/2024
- carton
Overview
Rx Only DESCRIPTION: This product is 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. Each gram contains 30 mg of lidocaine hydrochloride and 5 mg hydrocortisone acetate in a vehicle consisting of: aluminum sulfate, calcium acetate, cetyl alcohol, citric acid, glyceryl stearate (and) PEG-100 stearate, methylparaben, mineral oil, PEG-150 distearate, petrolatum, polycarbophil, propylene glycol, propylparaben, purified water, sodium citrate, sodium hydroxide, stearyl alcohol, xanthan gum.
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
: 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. Patient Directions for Rectal Administration: Remove moist wipe from box, tear open the package, gently clean the affected area and discard moist wipe. (Note: The moist wipe does not contain any of the prescribed active ingredients.) The cap and foil seal should be removed from the tube and the applicator tip firmly screwed onto the end of the tube and tightened. (Do not over tighten.) While holding the tube, gently squeeze the tube until a small amount of cream comes out of the applicator openings. This will lubricate the applicator tip. Gently insert the applicator tip into anal area. Continue squeezing the body of the tube as you move it around the areas of discomfort, and lastly, around and in the anal opening (if directed by physician). Do not completely insert the applicator and tube into the anus or insert deep into the rectum. Do not insert a loose applicator tip into the anus or rectum. Once application is completed, the tube and applicator tip should be gently removed and discarded.
Warnings & Precautions
WARNINGS: KEEP OUT OF REACH OF CHILDREN. Product, applicators and moist wipes could harm small children if chewed or swallowed. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue the use of this product and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Drug Interactions: Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: nitrates/nitrites (nitroglycerin, nitroprusside, nitric oxide, nitrous oxide); local anesthetics (benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine); antineoplastic agents (cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea); antibiotics (dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid); antimalarials (chloroquine, primaquine); anticonvulsants (phenytoin, sodium valproate, phenobarbital); other drugs (acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine). Patient Counseling Information: Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue. 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 contraindicated because of ototoxicity 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
: 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 on patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. These products are 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
During, immediately, or 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.
Storage & Handling
STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat.
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