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| Product NDC Code | 58980-824 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Lidocaine |
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| Type | Generic | ||||||||
| 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 | Stratus Pharmaceuticals Inc | ||||||||
| 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 4% (4g in 100g)
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 of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl 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 the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Local analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine Lidocaine Lidocaine Lidocaine Acrylamide CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) Allantoin ALOE VERA LEAF Benzyl Alcohol ALKYL (C12-15) BENZOATE ISOHEXADECANE Polysorbate 80 Propylene Glycol WATER SODIUM ACRYLOYLDIMETHYLTAURATE SODIUM LAURETH-3 SULFATE SOYBEAN LECITHIN .ALPHA.-TOCOPHEROL ACETATE
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 - 28.35 g Tube Box STRATUS PHARMACEUTICALS INC NDC 58980-824-30 Net WT. 1 oz. / 28.35 g LIDOCAINE CREAM 4% PAIN RELIEVING CREAM FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE PRINCIPAL DISPLAY PANEL - 28.35 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
Distributed by: Stratus Pharmaceuticals Inc. Miami, FL 33186
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 accidentally ingested, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call us at (800) 442-7882
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 consult a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days
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 avoid contact with the eyes do not use in large quantities, particularly over raw surfaces or blistered areas
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 20°C to 25°C (68°F to 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 avoid contact with the eyes do not use in large quantities, particularly over raw surfaces or blistered areas Stop use and consult a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days Lidocaine is NOT approved by FDA to treat teething pain and should NOT be given to infants and young children for this use. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.
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