Active Ingredients (W/W)
Lidocaine 5%
Phenylephrine HCL 0.25%
Secondary Numb Lidocaine Phenylephrine Gel
FDA Label NDC 83120-378
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lalani Rx Consulting, Inc. for the product Secondary Numb Lidocaine Phenylephrine Gel (NDC 83120-378). 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 ingredients (w/w), purpose, uses, warnings, do not use, ask a doctor before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local Anesthetic
Vaso Constrictor
Uses
• Temporary relief of pain
• Temporarily shrinks hemorrhoidal tissue
• For the temporary relief of anorectal discomfort associated with hemorrhoids
Warnings
For external use only
Do Not Use
if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination
Ask A Doctor Before Use If You Are
• presently taking medicine for high blood pressure or depression
When Using This Product
• do not put it into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
• bleeding occurs • condition worsens or does not improve within 7 days • redness, irritation, swelling, pain or other symptoms occur. If allergic reaction to product occurs.
Keep Out Of Reach Of Children.
If swallowed, call poison control centre or get medical help right away
Directions
Adults and children 12 years and over:
• Children under 12 consult a doctor
• Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product
• Apply to the affected area up to 3 times daily
• Do not use more often than directed
Inactive Ingredients
Aminomethylpropanol, Aqua, Benzyl Alcohol, Caprylyl Glycol, Carbomer, Phenoxyethanol, Propylene Glycol
Questions?
1-844-782-2387
Package Labeling:
Label (Label)
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