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| Product NDC Code | 0536-1278 | ||||
|---|---|---|---|---|---|
| Drug Name | Rugby lidocaine |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1421893 | ||||
| Application Number | M017 | ||||
| Labeler Name | RUGBY | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf juice, arginine, benzophenone-4, caprylyl glycol, cetyl alcohol, dimethyl sulfoxide, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, potassium sorbate, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.RUGBY LIDOCAINE LIDOCAINE LIDOCAINE LIDOCAINE ALOE VERA LEAF ARGININE SULISOBENZONE CETYL ALCOHOL DIMETHYL SULFOXIDE ANGOPHORA COSTATA WHOLE MELALEUCA ALTERNIFOLIA LEAF WATER JOJOBA OIL SODIUM POLYACRYLATE (2500000 MW) STEARIC ACID CAPRYLYL GLYCOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Rugby ® Maximum Strength Lidocaine 4% Pain and Itch Relief Cream NDC 0536-1278-03 Compare to the active ingredient in Gold Bond ® with 4% Lidocaine* NET WT 0.52 OZ (15 g) PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed by: RUGBY ® LABORATORIES Livonia, MI 48152
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in large quantities, particularly over raw surfaces or blistered areas.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-645-2158
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days rash or irritation develops, persists, or increases
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 15 to 30°C (59 to 86°F) This package is child-resistant
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. Avoid contact with eyes. Not for prolonged use. Do not use in large quantities, particularly over raw surfaces or blistered areas. Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days rash or irritation develops, persists, or increases If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API