Active Ingredient
Lidocaine 4%
Anixike Numbing Cream
FDA Label NDC 85248-166
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 Anixike Numbing (NDC 85248-166). 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
Topical Analgesic
Use
■ Temporarily relieves local pain and discomfort of anorectal area
Warnings
For external use only.
Do Not Use
■ Do not apply to eyes, broken skin, or mucous membranes.
■ Do not put this product into the rectum by using fingers or any mechanical device or applicator.
When Using
■ If swallowed, get medical help.
■ Do not use if allergic to any ingredients.
■ If pregnant or breastfeeding, ask a health professional before use.■ Do not apply to eyes, broken skin, or mucous membranes.
■ Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use
■ Stop use and ask a doctor if condition worsens or symptoms persist.
■ Condition worsens or does not improve within 7 days.
■ Allergic reaction occurs to ingredients in this product.
■ Symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
■ Symptoms clear up and return within a few days.
Ask Doctor
■ Stop use and ask a doctor if condition worsens or symptoms persist.
■ Condition worsens or does not improve within 7 days.
■ Allergic reaction occurs to ingredients in this product.
■ Symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
■ Symptoms clear up and return within a few days.
Keep Oot Of Reach Of Children
Keep out of reach of children
Directions
■ Adults and children 12 years and older: Apply to affected area not more than 3 to 4 times daily.
■ Children under 12 years of age: Ask a doctor.
Other Information
■ Store between 15–30°C (59–86°F). Avoid freezing and excessive heat above 40°C (104°F).
Inactive Ingredients
■Water ,Carbomer 934,Propylene Glycol,Soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.
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