Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream

DESCRIPTION

DESCRIPTION SECTION

Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: C 14 H 22 N 2 O Mol. wt. 234.34 Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula: C 23 H 32 O 6 Mol. wt. 404.50

ACTIVE INGREDIENTS

SPL UNCLASSIFIED SECTION

LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 0.5%

INACTIVE INGREDIENTS

SPL UNCLASSIFIED SECTION

Aloe barbadensis leaf extract, cetyl alcohol, glycerin, glyceryl stearate SE, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, stearyl alcohol, white petrolatum, xanthan gum.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

INDICATIONS

INDICATIONS & USAGE SECTION

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.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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.

WARNINGS

WARNINGS SECTION

For external use only. Not for ophthalmic use. Product 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.

PRECAUTIONS

PRECAUTIONS SECTION

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. If extensive areas are treated, the possibility of systemic absorption exists. Systemic absorption of topical steroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestation of Cushing's syndrome, hyperglycemia, and glycosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of potent topical steroids applied to a large surface area, or under an occlusive dressing, should be evaluated periodically for evidence of HPA axis suppression. If noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of the HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. If irritation develops, topical steroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

HOW SUPPLIED

HOW SUPPLIED SECTION

Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 1 oz (28.3g) tube - NDC 69367-397-01 Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 3 oz (85g) tube - NDC 69367-397-85

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 Rev. 05/24

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69367-397-85 Rx Only Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream Anti-Inflammatory Anesthetic FOR EXTERNAL USE ONLY NOT FOR OPTHALMIC USE. Westminster Pharmaceuticals