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| Product NDC Code | 84028-111 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Bliss republic lidocaine numbing 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 | ||||||||
| Application Number | M017 | ||||||||
| Labeler Name | Sargass Group Limited Liability Company | ||||||||
| 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(s) LIDOCAINE 5%_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Local Anesthetic
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: Before applying this product, gently dry the application area by patting or blotting it with toilet tissue or a clean, soft cloth. Apply up to 6 times daily. Children under 12 years: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Carbomer 934, Arnica, Emu oil, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Menthol, Water Floral scent
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.Use For temporary relief of local and anorectal discomfort, itching, pain, soreness, or burning associated with anorectal disorder or inflammation.
Purpose
Information about the drug product’s indications for use.Purpose Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Bliss Republic Lidocaine Numbing Cream Lidocaine Numbing Cream WATER LECITHIN, SOYBEAN MENTHOL CARBOMER 934 LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS ALPHA-TOCOPHEROL ACETATE ARNICA MONTANA FLOWER PROPYLENE GLYCOL BENZYL ALCOHOL
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.Package Label - Principal Display Panel 30mL NDC: 84028-111-11 Cream-label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Notice: · Alcohol Avoidance: Refrain from consuming alcohol 24 hours before your skin treatment. Alcohol consumption may reduce the effectiveness and duration of the product used during the skin procedure. · Please note that the duration of the numbing effect may vary based on factors like temperature and individual skin types. Ultimate Numbing Experience Recommended steps: Perform a spot test a day before your scheduled skin procedure. Apply a small amount of the cream to a clean and limited area for 10-20 minutes to check for any adverse reactions, especially if you have sensitive skin. Cleanse and exfoliate the intended area with soap and water to remove dirt and dead skin. Ensure dry skin before applying the cream. Apply a generous 2 mm-thick layer of numbing cream to the specified area without rubbing it in. Ensure the cream covers the intended area and its immediate surroundings. Wrap the creamed area securely with cling film, ensuring a tight seal. Keep the cream and wrap in place for 40-60 minutes. Take off the plastic wrap and gently wipe off any extra cream. Wait an additional 15 minutes for the maximum numbness effect to be reached. Begin the procedure. Customer Care: For any questions, please contact us for a quick and satisfactory solution: [email protected] Distributed by Sargass Group LLC, Casper, WY 82601 312 W 2nd St, A3007 +1 307 333 9039
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 away from children. Avoid contact with eyes. In case of accidental ingestion, seek medical attention immefiately.
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.Discontinue use and consult a doctor if: The treated symptoms show no signs of improvement, or if redness, irritation, swelling, pain, or other symptoms manifest or worsen. Seek immediate medical attention in such cases.
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: Adhere to the recommended daily dosage unless otherwise directed by a doctor. Some individuals with heightened sensitivity might experience allergic reactions to specific ingredients in this product. Do not insert this cream into the rectum using fingers, applicators, or any medical devices.
Storage and handling
Information about safe storage and handling of the drug product.Other information Additional Information: Store at room temperature. Avoid direct sunlight. Refrain from using if packaging has been damaged or is missing.
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) Before usage: Avoid using this product if you have a known allergy to lidocaine. Do not use while pregnant or breastfeeding. In case of accidental overdose, seek immediate medical assistance or contact the Poison Control Center.
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