Active Ingredient(S)
LIDOCAINE 5%_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Local Anesthetic
Bliss Republic Lidocaine Numbing Cream
FDA Label NDC 84028-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sargass Group Limited Liability Company for the product Bliss Republic Lidocaine Numbing Cream (NDC 84028-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, otc - when using, otc - keep out of reach of children, otc - stop use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Use
For temporary relief of local and anorectal discomfort, itching, pain, soreness, or burning associated with anorectal disorder or inflammation.
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.
Otc - When Using
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.
Otc - Keep Out Of Reach Of Children
Keep away from children. Avoid contact with eyes. In case of accidental ingestion, seek medical attention immefiately.
Otc - Stop Use
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.
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.
Other Information
Additional Information:
Store at room temperature. Avoid direct sunlight. Refrain from using if packaging has been damaged or is missing.
Inactive Ingredients
Carbomer 934, Arnica, Emu oil, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Menthol, Water Floral scent
Recent Major Changes
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:
Distributed by Sargass Group LLC, Casper, WY 82601
312 W 2nd St, A3007
+1 307 333 9039
Package Label - Principal Display Panel
Cream-label (Image Cream 30)
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