Active Ingredient
Lidocaine 5%
Lidocaine
FDA Label NDC 82927-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chengdu Discount Trading Co.ltd for the product Lidocaine (NDC 82927-001). 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, do not use, when using this product, stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local Anesthetic
Uses
for temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation
Warnings
Warnings ( For extemal use only )
Do Not Use
Do not use this product if
pregnant or breastfeeding , ask a health professional before use.
in case of accidental overdose , get medical help or contact the Poison Control Center immediately.
tamper evident " Do not use this product " if seal is broken or missing.
When Using This Product
do not exceed the recommended daily dosage unless directed by a doctor.
certain persons can develop allergic reactions to ingredients in this product.
do not put this product into the rectum by using finger or any medical device or applicator.
Stop Use
n/a
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Incase of accidental ingestion , seek medical attention immediately
Directions
Adults : When practical , cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blottingwith toilet tissue or a soft cloth , before application of this product.
Apply up to 6 times a day,
Children up under 12 years of age: consult a doctor.
Other Information
keep away from direct sunlight or heata.
store in room temperature ( 59-86 F/15-30 C )
Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimenthyl Isosorbide, Disodium EDTA , Hydrogenated Polydece, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Acetate, Trideceth-6, Triethanolamine
Package Label - Principal Display Panel
82927-001-01 (82927 001 01)
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