Active Ingredient
Lidocaine 4%
Yysdmvy Numbing Cream
FDA Label NDC 85248-209
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 Yysdmvy Numbing Cream (NDC 85248-209). 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 pain and itching associated with:
·minor burns
·sunburn
·minor cuts
·scrapes
·insect bites
·minor skin irritations
Warnings
For external use only.
Do Not Use
·on children under 12 years of age
·in large quantities, particularly over raw surfaces or blistered areas
·if allergic to lidocaine or any ingredient in this product
When Using
·avoid contact with eyes
·do not exceed recommended dosage
·do not insert into rectum using fingers or mechanical applicators
Stop Use
If discomfort persists for 7 days.
The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.
Ask Doctor
If discomfort persists for 7 days.
The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.
Keep Out Of Reach Of Children
Avoid contact with eyes. In case of accidental ingestion, seek medical attention immediately.
Directions
For children under 12, consult a doctor.
For adults: If possible, clean the affected area with mild soap and warm water, making sure to rinse thoroughly.
Gently dry the area with toilet tissue or a soft cloth before applying the product.
Apply up to 4 times daily.
Other Information
Store room temperature 59°‑86°F (15°‑30°C).
Keep away from direct sunlight or heat.
Inactive Ingredients
Carbomer 934, Lecithin (Soybean), Emu Oil, Arnica, Propylene Glycol, Tocopheryl Acetate, Benzyl Alcohol, Aqua.
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