Advanced Numb Topical Anesthetic Cream
FDA Label NDC 71131-052
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Uber Scientific, Llc for the product Advanced Numb Topical Anesthetic (NDC 71131-052). 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 drug facts, active ingredients, purpose, use, warnings, do not, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine HCL (5%)
Purpose
External Analgesic
Use
For the temporary relief of pain and discomfort associated with anorectal disorders.
Warnings
For external use only. If condition worsens or does not improve within 7 days, consult a doctor.
Do Not
exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, Consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact the Poison Control Center immediately.
Directions
Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product.
Apply externally up to 6 times per day.
Children under 12: Consult a Doctor.
Inactive Ingredients
Allantoin Gel, Deionized Water, Benzyl Alcohol, Carbomer, Pro-pylene GLycol, Sodim Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine
Other Information
Store at room temperature. Avoid Direct sunlight.
Package Labeling:
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