Lidocaine 3% - Hydrocortisone 0.5% Cream

Rx Only

Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain Swelling and Inflammation

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.

ACTIVE INGREDIENTS: Each gram of Lidocaine 3% - Hydrocortisone 0.5% Cream contains lidocaine hydrochloride 3% (30mg) and hydrocortisone acetate 0.5% (5 mg).

INACTIVE INGREDIENTS: aluminum sulfate, calcium acetate, cetyl alcohol, hydrochloric acid, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan stearate, stearic acid, stearyl alcohol, and white petrolatum.

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.

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.

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.

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, manifestations 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 cortico-steroids 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.

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.

Lidocaine is excreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when lidocaine is administered to a nursing woman.

Safety and efficacy in children have not been established.

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.

You may report side effects to the FDA at 1-800-FDA-1088.

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.

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.

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

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