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| Product NDC Code | 0536-1139 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Rugby Laboratories | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine HCL 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 over 12 years: apply a thin layer ot affected area every 6 t o8 hours, not to exceed 3 applications in a 24 hour period Children under 12 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21, Water (purified)
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.Uses Temporarily relieves minor pain
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Rugby Lidocaine Lidocaine LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS WATER SILICON ALCOHOL CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) DIMETHICONE 350 AMINOMETHYLPROPANOL ETHYLHEXYLGLYCERIN PHENOXYETHANOL STEARETH-21 GLYCERYL MONOSTEARATE EDETATE DISODIUM ANHYDROUS ALOE VERA LEAF CETEARETH-2 PHOSPHATE
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 Panel-Tube RUGBY ® NDC 0536-1139-20 Maxium Strength 4% Lidocaine Pain Relieving Cream NET WT. 15g (0.52 oz) Principal Panel-Tube
Principal Panel - Carton RUGBY® NDC 0536-1139-20 Maxium Strength 4% Lidocaine Pain Relieving Cream NET WT. 15g (0.52 oz) Principal Panel - 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
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 on large areas of the body or on cut,irritated or swollen skin on puncture wounds for more than one week without consultanting a doctor When using this product use only as directed. read and follow all directions and warnings on this carton. do notallow contact with the eyes do not bandage or apply local heat (such as heating pads) to the area of use.
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 this and all drugs out of the reach of children and pets. If swallowed, get medical help or contact Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at controlled room temperature 20°-25°C (68°-77°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions?(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 symptons persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast feeding , ask a health professional before use.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product use only as directed. read and follow all directions and warnings on this carton. do notallow contact with the eyes do not bandage or apply local heat (such as heating pads) to the area of use.
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 Do not use on large areas of the body or on cut,irritated or swollen skin on puncture wounds for more than one week without consultanting a doctor When using this product use only as directed. read and follow all directions and warnings on this carton. do notallow contact with the eyes do not bandage or apply local heat (such as heating pads) to the area of use. Stop use and ask a doctor if condition worsens symptons persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast feeding , ask a health professional before use. Keep this and all drugs out of the reach of children and pets. If swallowed, get medical help or contact Poison Control Center right away.
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