Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Lidocaine 3% - Hydrocortisone 0.5% Cream is supplied as a white cream in: 1 oz (28.35 g) tubes NDC 13925-160-01 3 oz (85 g) tubes NDC 13925-160-03 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-77°F). See USP Controlled Room Temperature. Protect from freezing.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rx Only NDC-13925-160-03 Net Wt. 3 oz. (85 g) Lidocaine 3% Hydrocortisone 0.5% Cream Anti-Inflammatory Anesthetic FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. SETON PHARMACEUTICALS Lidocaine 3% - Hydrocortisone 0.5% Cream
- HOW SUPPLIED: Lidocaine 3% - Hydrocortisone 0.5% Cream is supplied as a white cream in: 1 oz (28.35 g) tubes NDC 13925-160-01 3 oz (85 g) tubes NDC 13925-160-03 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-77°F). See USP Controlled Room Temperature. Protect from freezing.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rx Only NDC-13925-160-03 Net Wt. 3 oz. (85 g) Lidocaine 3% Hydrocortisone 0.5% Cream Anti-Inflammatory Anesthetic FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. SETON PHARMACEUTICALS Lidocaine 3% - Hydrocortisone 0.5% Cream
Overview
Lidocaine 3% - Hydrocortisone 0.5% Cream 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.
Indications & Usage
INDICATIONS: Product is used for the anti-inflammatory and anesthetic relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes.
Dosage & Administration
: Apply product to the affected area(s) twice daily or as directed by a physician. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of the physician.
Warnings & Precautions
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 on patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. This 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. structure structure2
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
KEEP THIS AND ALL MEDICATIONS OUT OF 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: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 Iss. 5/11 Rx Only Seton Pharmaceuticals
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.