LIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE

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: NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55% image description image description

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. 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. Products without Applicators: Remove the child-resistant cap and foil seal from the tube. Apply a thin film to the affected area. Replace the cap after use. Products with Single-Use Tubes and Applicators: Tear open one cleansing wipe packet (if the product kit contains such item), gently clean the affected area and discard the used cleansing wipe. Remove the child-resistant cap and foil seal from one tube and firmly screw one applicator onto the tube. Do not over tighten. Squeeze the tube to fill the applicator until a small amount of cream/gel comes out of and lubricates the applicator openings. 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, both the tube and applicator should be gently removed and discarded. PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe: Remove the cap and foil seal from the tube and attach one applicator onto the tube. Do not over tighten. Squeeze the tube to fill the applicator until the plunger stops. While maintaining neutral pressure on the tube, separate the applicator from the tube. Replace the cap, roll the tube up from the bottom and save for future use. Gently insert the tip of the filled applicator approximately ½ inch into the anal area and apply steady, even pressure on the plunger, applying 5 mL of gel to the anus and peri-anal area. Do not insert the applicator any additional length into the anus. Once application is completed, remove the applicator and discard. After the final use, also discard the tube. If directed by a physician, a small amount of gel may be applied to the anal area using a fingertip.

: 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.

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 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Protect from freezing.