Active Ingredient
Lidocaine 5%
Puvida Numbing Cream Anorectal (hemorrhoidal) Cream
FDA Label NDC 85248-224
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Puvida Numbing Cream Anorectal (hemorrhoidal) Cream (NDC 85248-224). 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, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local Anesthetic
Use
For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders.
Warnings
For external use only.
Do Not Use
on damaged or broken skin.
When Using
When using this product-Use only as much as recommended, unless a doctor advises otherwise.
Do not insert into the rectum with fingers or any mechanical device or applicator.
Stop Use
Stop and consult a doctor if
An allergic reaction is observed.
Symptoms such as redness, irritation, swelling, pain, or others begin or worsen.
Does not show improvement within 7 days.
Ask Doctor
Stop and consult a doctor if
An allergic reaction is observed.
Symptoms such as redness, irritation, swelling, pain, or others begin or worsen.
Does not show improvement within 7 days.
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults: When practical, clean the area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
Children under 12 years of age: Consult a doctor.
Apply externally to the affected area up to 6 times daily.
Inactive Ingredients
Water, Carbomer 934, Propylene Glycol, Soybean Lecithin, Alpha-Tocopherol Acetate, Benzyl Alcohol.
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