{"active_ingredient":["Active ingredient Lidocaine 4.0%"],"do_not_use":["Do Not Use in large quantities, particularly over raw surfaces or blistered areas."],"dosage_and_administration":["Directions • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor."],"effective_time":"20241120","id":"66692881-80cc-4cc3-82b0-ab8946bae60c","inactive_ingredient":["Inactive Ingredients butylated hydroxytoluene, cetostearyl alcohol, citric acid, edetate disodium, light mineral oil, methylparaben, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium citrate, and white petrolatum."],"indications_and_usage":["Uses Temporarily relieves pain due to: • sunburn • minor burns • insect bites • minor cuts • minor scraps • minor skin irritations"],"indications_and_usage_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"49%\"/><col width=\"49%\"/><tbody><tr><td valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>sunburn</item></list></td><td valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>minor burns</item></list></td></tr><tr><td valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>insect bites</item></list></td><td valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>minor cuts</item></list></td></tr><tr><td valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>minor scraps</item></list></td><td valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>minor skin irritations</item></list></td></tr></tbody></table>"],"keep_out_of_reach_of_children":["Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel Rugby® NDC 0536-1281-28 Lidocaine Cream 4% Net Wt. 30 grams For Topical Use Only Do Not Use in the Eyes 4.0% carton"],"purpose":["Purpose Topical anesthetic"],"questions":["Questions? Call 1-800-645-2158"],"set_id":"21ea06f4-813e-419e-9b87-1eb04d48097e","spl_product_data_elements":["Lidocaine 4% Cream Lidocaine LIDOCAINE LIDOCAINE BUTYLATED HYDROXYTOLUENE CETOSTEARYL ALCOHOL CITRIC ACID ACETATE EDETATE DISODIUM ANHYDROUS LIGHT MINERAL OIL METHYLPARABEN POLYOXYL 20 CETOSTEARYL ETHER PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM PETROLATUM"],"spl_unclassified_section":["RETAIN CARTON FOR COMPLETE DRUG FACTS To open, push down cap while turning counter-clockwise and lift off. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. See crimp of tube for Lot No. and Exp. Date Distributed bu: RUGBY LABORATORIES 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 www.rugbylaboratories.com Rev. 12/19 R-170 Re-order No. 370992","Insert LIDOCAINE 4% Cream DESCRIPTION Lidocaine 4% cream is a non-greasy cream specially formulated with soothing agents, indicated as a topical anesthetic for use on normal intact skin for local analgesia and itching due to minor cuts, minor scrapes, sunburn, minor skin irritations, minor burns and insect bites. INGREDIENTS ACTIVE: Lidocaine (4%) INACTIVE: Butylated Hydroxytoluene, Cetostearyl Alcohol, Citric Acid, Edetate Disodium, Light Mineral Oil, Methylparaben, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and White Petrolatum. The chemical designation of Lidocaine is 2-(diethylamino)-N(2,6-dimethylphenyl), acetamide. The structure of lidocaine is: structural formula MECHANISM OF ACTION Lidocaine 4% cream applied to intact skin provides dermal analgesia by the release of lidocaine from the cream into the epidermis and dermis. Lidocaine is a local anesthetic agent of the amide type. Local anesthetics reversibly block the initiation and conduction of nerve impulses by interfering with the flux of sodium ions through the neuronal membrane. The onset, depth and duration of dermal analgesia provided depend upon the site and duration of application. INDICATIONS AND USAGE Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites. Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas. CONTRAINDICATIONS Lidocaine 4% cream is contraindicated in patients with sensitivity to amide type local anesthetics or to any component of the product. WARNINGS For external use only. Avoid contact with the eyes. Do not use over large areas of the body. Do not use for more than seven days unless directed by a doctor. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Inappropriate use of this product, such as on large areas of the body, application on mucous membranes, or on individuals that are allergic to the amide type anesthetics, may result in serious side effects. Consultation with a doctor before using this product is strongly recommended. PRECAUTIONS Repeated doses of lidocaine 4% cream may increase blood levels of lidocaine. Avoid contact with the eyes. If eye contact occurs, immediately wash out the eye with water or saline. The patient should be aware that dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing or exposure to extreme hot or cold temperatures until complete sensation has returned. DRUG INTERACTIONS Lidocaine 4% cream should be used with caution in patients receiving Class I antiarrhythmic agents (e.g., tocainide, mexiletine) since the toxic effects are potentially additive and synergistic. DIRECTIONS • Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day. • Children under 2 years of age: Consult a doctor. HOW SUPPLIED NDC 0536-1281-28 (30 gram tubes) Store at USP controlled room temperature 20° to 25°C (68° to 77°F). Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310 Distributed by: RUGBY LABORATORIES 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 C101500 Revised 01/2020"],"spl_unclassified_section_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"33%\"/><col width=\"33%\"/><col width=\"33%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Rev. 12/19</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>R-170</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Re-order No. 370992</paragraph></td></tr></tbody></table>"],"stop_use":["Stop Use and ask doctor if • condition gets worse • symptoms last more than 7 days • symptoms clear up and occur again in a few days."],"version":"2","warnings":["Warnings For external use only. Do Not Use in large quantities, particularly over raw surfaces or blistered areas. When Using this product • keep out of eyes • use only as directed. Stop Use and ask doctor if • condition gets worse • symptoms last more than 7 days • symptoms clear up and occur again in a few days."],"when_using":["When Using this product • keep out of eyes • use only as directed."]}