Active Ingredient
Lidocaine 5%
Numbing Cream Emulsion
FDA Label NDC 82929-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sainite Trading Shenzhen Co., Ltd. for the product Numbing Cream (NDC 82929-011). 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, keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anorectal (Hemorrhoidal)
Uses
For temporary relief of local itching and discomfort Associated with anorectal disorders
Warnings
For external use only.
If condition worsens or does not improve within 7 days, consult a doctor.
Do not exceed the recommended daily dosage unless directed by a doctor.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.
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.
Keep Out Of Reach Of Children
if swallowed get medical help or contact a Poison Control Center right away.
Directions
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Children under 12 years of age: consult a doctor.
Apply externally to the affected area. Apply to the affected area up to 6 times daily.
Inactive Ingredients
Aloe barbadebsis lesf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Carbomer, Triethanolamine
Other Information
Store at room temperature (59-86 *F/15-30℃ ).
Keep away from direct sunlight or heat.
Keep out the reach of children. The package is child-resistant.
Do not use this product if seal is broken or missing
In case of accidental overdose and ingestion, call a doctor immediately.
82929-011
82929-011 (82929 011)
* Please review the disclaimer below.
