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| Product NDC Code | 69805-786 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Zensa |
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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 | 1366789, 1729173 |
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| Application Number | M015 | ||||||
| Labeler Name | Alera Skin Care Products 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 5%
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: when practical, cleanse the affected area with mild soap, and warm water and rinse thoroughly. Gently dry by patting or blottig with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a physician. Apply externally to the affected area up to 6 times daily
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Vitamin E Acetate, Purified Water
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 local discomfort associated with anorectal disorders For the temporary relief of pain, soreness, and burning
Purpose
Information about the drug product’s indications for use.Purpose Topical Anaesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Zensa Lidocaine BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) LECITHIN, SOYBEAN PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE WATER 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.PRINCIPAL DISPLAY PANEL - 1 oz Tube Carton zensa LIDOCAINE CREAM WITH 5% LIDOCAINE alera SKINCARE NDC 69805-786-01 1 oz PRINCIPAL DISPLAY PANEL - 1 oz Tube Carton
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 medical help or contact a 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 See enclosed consumer leaflet. Store at 15°C to 30°C. Protect from freezing
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 or does not improve within 7 days bleeding occurs
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 do not exceed the recommended daily dosage unless directed by a physician do not put this product into the rectum by using fingers or any mechanical device or applicator certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor
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 eyes do not exceed the recommended daily dosage unless directed by a physician do not put this product into the rectum by using fingers or any mechanical device or applicator certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor
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