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Product NDC Code | 69375-005 | ||||
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Drug Name | Lidocaine anesthetic cream |
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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 | Nationwide Pharmaceutical LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Lidocaine 4% w/w
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 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.
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 For temporary relief of pain associated with minor cuts, minor burns, minor scrapes, sunburn, minor skin irritations, and insect bites.
Purpose
Information about the drug product’s indications for use.Purpose Local Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine Anesthetic Cream Lidocaine Lidocaine Lidocaine Benzyl alcohol CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) Cholesterol HYDROGENATED SOYBEAN LECITHIN Isopropyl Myristate Polysorbate 80 Trolamine .ALPHA.-TOCOPHEROL ACETATE, D-
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 - 28 g Tube Box Nationwide Pharmaceutical NDC 69375-0005-30 4% Lidocaine Topical Anesthetic Cream NET WT 1 oz ( 28 g) PRINCIPAL DISPLAY PANEL - 28 g Tube Box
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
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 help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-697-3329
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 allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase.
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 do not get into eyes. do not exceed the recommended daily dosage unless directed by a doctor do not use in large quantities, particularly over raw or blistered areas.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding , ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at USP controlled room temperature 20-25 °C (68-77 °F).
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. When using this product do not get into eyes. do not exceed the recommended daily dosage unless directed by a doctor do not use in large quantities, particularly over raw or blistered areas. Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase. If pregnant or breastfeeding , ask a health professional before use. Keep out of reach of children. If swallowed, get help or contact a 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