Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 1 oz (28.3g) tube - NDC 69367-397-01 Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 3 oz (85g) tube - NDC 69367-397-85 To report a serious adverse event or obtain product information, call 1-844-221-7294. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Temperature]. Protect from freezing.; PRINCIPAL DISPLAY PANEL - 85 g Tube Carton NDC 69367-397-85 Rx Only Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream Anti-Inflammatory Anesthetic FOR EXTERNAL USE ONLY NOT FOR OPTHALMIC USE. Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
- HOW SUPPLIED Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 1 oz (28.3g) tube - NDC 69367-397-01 Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 3 oz (85g) tube - NDC 69367-397-85 To report a serious adverse event or obtain product information, call 1-844-221-7294. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Temperature]. Protect from freezing.
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton NDC 69367-397-85 Rx Only Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream Anti-Inflammatory Anesthetic FOR EXTERNAL USE ONLY NOT FOR OPTHALMIC USE. Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
Overview
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: C 14 H 22 N 2 O Mol. wt. 234.34 Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula: C 23 H 32 O 6 Mol. wt. 404.50 Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream Each gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 5 mg. Chemical Structure Chemical Structure
Indications & Usage
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.
Dosage & Administration
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 used in the anal canal. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advise 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.
Warnings & Precautions
WARNINGS For external use only. Not for ophthalmic use. Product 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.
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 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.
Adverse Reactions
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.
Storage & Handling
To report a serious adverse event or obtain product information, call 1-844-221-7294. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Temperature]. Protect from freezing.
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