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| Product NDC Code | 44577-704 | ||||
|---|---|---|---|---|---|
| Drug Name | Lidostat |
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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 | 1010895, 1427002 |
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| Application Number | M017 | ||||
| Labeler Name | Clinical Therapeutic Solutions | ||||
| 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: For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day. Children under 2 years of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bin Vinyl Dimethicone/Dimethicone Copolymer, C13-14 Isoparaffin, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Laureth-7, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Stearic Acid, Triethanolamine, Urea.
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 and itching caused by minor skin irritations.
Purpose
Information about the drug product’s indications for use.Purpose External Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.LidoStat LIDOCAINE HCL ALOE VERA LEAF WATER C13-14 ISOPARAFFIN CETYL ALCOHOL DIMETHICONE ETHYLHEXYLGLYCERIN LAURETH-7 DIMETHYL SULFONE PHENOXYETHANOL POLYSORBATE 20 STEARIC ACID TROLAMINE UREA LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS
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.LidoStat CREAM Lidocaine HCI 4% In a 20% Urea Vehicle MEDICAL STRENGTH PAIN CREAM PENETRATING FORMULA Dipensed Only by Physicians NET WT. 2.0 oz (56 g) LOT: EXP:
LidoStat CREAM 2oz/56g (44577-704-02) Inner Label Outer Label
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.LidoStat CREAM
Other information: Store at room temperature (68-77ºF) (20º-25ºC)
LidoStatTM Cream Distributed by: CLINICAL THERAPEUTIC SOLUTIONS A Part of bako's Integrated Physician Solution PO Box 1257, Wall, NJ 07719 732.894.9450 • www.BakoCTS.com
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 children under 2 years of age unless directed by a physician.
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, consult a physician.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Question or Comments? Please visit www.BakoCTS.com
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: symptoms persist for more than seven days, or clear up and occur again within a few days. redness, irritation, swelling, pain or other symptoms 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 avoid contact with eyes Use only as directed. Do not use in large quantities, particularly over raw surfaces or blistered areas.
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 children under 2 years of age unless directed by a physician. When using this product avoid contact with eyes Use only as directed. Do not use in large quantities, particularly over raw surfaces or blistered areas. Stop use and ask a doctor if: symptoms persist for more than seven days, or clear up and occur again within a few days. redness, irritation, swelling, pain or other symptoms increase Keep out of reach of children. If swallowed, consult a physician.
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