LIDOCAINE HCL - HYDROCORTISONE ACETATE

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: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula: INGREDIENTS: PharmaPure Rx Lidocaine HCl 2% - Hydrocortisone Acetate 2% Cream Each gram contains Lidocaine HCl 20 mg, Hydrocortisone Acetate 20 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2% HYDROCORTISONE ACETATE 2% structure structure

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.

: Apply product to the affected area(s) twice daily or as directed by a physician. 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, squeeze the tube to fill the applicator until a small amount of cream/gel shows and lubricates the end of the tip with cream/gel. Gently insert the applicator tip with attached tube into anal area. Continue squeezing the body of the tube as it is moved 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 from the area and disposed. Note that an adequate amount of product for an application to the anal and peri-anal area will be applied through the applicator tip by gently squeezing the tube during application. 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.

: 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.

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.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.