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| Product NDC Code | 71085-075 | ||||
|---|---|---|---|---|---|
| Drug Name | Lidocaine cream, 4% |
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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 | IPG 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%
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 Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorabte-20, Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Triethanolamine.
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,sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.
Purpose
Information about the drug product’s indications for use.Purposes Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine Cream, 4% Lidocaine ALOE VERA LEAF WATER CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN GLYCOL STEARATE GLYCERYL MONOSTEARATE SUNFLOWER OIL PHENOXYETHANOL POLYSORBATE 60 JOJOBA OIL STEARIC ACID TROLAMINE LIDOCAINE LIDOCAINE
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.Product label image description
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.Other Information Store at 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.Warning Warnings for External Use only Avoid contact with eyes Do not use in large quantities, particularly over raw surface or blistered area Stop Use and Ask a Doctor if condition worsens or if symptoms persist for more than 7 days or occur again within a few days. Keep out of reach of children .If swallowed, get medical 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