Warnings
For external use only.
Avoid contact with eyes.
Patch test before full use.
Discontinue use if irritation occurs.
Keep out of reach of children.
Signature Lidocaine Pain Relief Cream
FDA Label NDC 84019-043
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shengnan (guangzhou) Cosmetics Co., Ltd for the product Signature Lidocaine Pain Relief Cream (NDC 84019-043). 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 warnings, otc - purpose, otc - stop use, otc - active ingredient, otc - when using, inactive ingredient, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anorectal (Hemorrhoidal)
Otc - Stop Use
Allergic reaction or
rectal bleeding occurs.
Redness, irritation,
swelling, or pain increases.
Condition worsens or
lasts >7 days
Otc - Active Ingredient
5% Lidocaine
Otc - When Using
Temporary relief of pain,itching, soreness, or burning in the perianal area from anorectal disorders.
Inactive Ingredient
Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Mentha Arvensis Leaf Extract, Chrysanthemum Indicum Extract, Portulaca Oleracea Extract,
Propylene Glycol, Tocopheryl Acetate, Water
Dosage & Administration
Adults and children 12
years and older: Apply a
thin layer to the affected
area 1-3 times daily or
as directed by a
healthcare provider.
Indications & Usage
Wash the area with soap. Apply a 2 mm-thick layer, rub it in for 1–2 minutes, and cover with a waterproof
film approximately 90 minutes before your procedure. Scan the QR code for detailed directions.
Otc - Keep Out Of Reach Of Children
Keep out of reach of
children.
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