Active Ingredient
Lidocaine 5% and Phenylephrine hydrochloride 0.25%
Zensa Numbing Gel
FDA Label NDC 69805-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alera Skin Care Products Inc. for the product Zensa Numbing Gel (NDC 69805-400). 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, purpose, uses, warnings, stop use and ask a doctor if:, keep out of reach of children, directions, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local Anaesthetic
Vasoconstrictor
Protective
Uses
For temporary relief of local discomfort associated with anorectal disorders. For temporary
relief of pain, soreness and burning. Temporarily shrinks hemorrhoidal tissue.
Warnings
For external use only.
Before use ask a doctor:
•if you are presently taking a prescription drug for high blood pressure or depression.
When using this product:
•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.
Do not use this product if you have
heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland
unless directed by a doctor.
Stop Use And Ask A Doctor If:
•condition worsens or does not improve within 7 days
•bleeding occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Children under 12 years of age: Consult a doctor.
Apply externally to the affected area up to 4 times daily.
Storage And Handling
Other Information
See enclosed consumer leaflet prior to use. Store at 59°-86°F.
Protect from freezing.
Inactive Ingredient
Benzyl Alcohol, Carbomer, Caprylyl Glycol, Propylene Glycol, Phenoxyethanol, Purified Water.
Questions
Questions? 1-844-441-7546
* Please review the disclaimer below.
