Label: LIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE- lidocaine hcl and hydrocortisone acetate gel

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%

ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, CITRIC ACID, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PEG-4, PROPYLENE GLYCOL, PROPYLPARABEN, PURIFIED WATER.

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.

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.

For external use only.Not for ophthalmic use.Product and used applicators 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.

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.

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.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

Safety and efficacy in children have not been established.

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.

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.

PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe contains one (1) Multi-use 100g tube and 15 single-use applicators. NDC 59088-817-01.

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