Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Lidotral® 3.88% + Hydrocortisone 1% Cream (Lidocaine HCl 3.88% - Hydrocortisone Acetate 1%) is supplied as an off-white cream in a 3 oz. (85 g) tube with CRC Cap - NDC 59088-317-07; Lidotral® 3.88% + Hydrocortisone 1% Cream Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Label
- HOW SUPPLIED: Lidotral® 3.88% + Hydrocortisone 1% Cream (Lidocaine HCl 3.88% - Hydrocortisone Acetate 1%) is supplied as an off-white cream in a 3 oz. (85 g) tube with CRC Cap - NDC 59088-317-07
- Lidotral® 3.88% + Hydrocortisone 1% Cream Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Label
Overview
Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula: new image description
Indications & Usage
INDICATIONS: For the temporary relief of pain and itching associated with minor burns, sunburns or minor skin irritations or hemorrhoids and itching associated with inflammation, and rashes due to eczema.
Dosage & Administration
: Apply product to the affected area(s) twice daily or as directed by a licensed healthcare practitioner. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician. Wash hands before and after application.
Warnings & Precautions
WARNINGS: CONCERNS RELATED TO ADVERSE EFFECTS: Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (including pale, gray, or blue-colored skin (cyanosis), headache, rapid pulse, shortness of breath, lightheadedness, fatigue). WARNINGS: For external use only. Not for ophthalmic use. 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 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
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.
Storage & Handling
KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].
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