Active Ingredients
Lidocaine 4% w/w
Lidocaine Cream
FDA Label NDC 83589-302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nanjing Chengong Pharmaceutical Co., Ltd. for the product Lidocaine (NDC 83589-302). 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 ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Uses
For the temporary relief of pain, itching and burning associated with hemorrhoids and other anorectal disorders.
Warnings
For external only.
When Using This Product
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reaction occurs
- symptoms 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 Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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 soft cloth before applying.
- Adults and children 12 years and older: apply eyternally to the attected area un to 6 times a day.
- Children under 12 years of age: consult a doctor.
Other Information
Store at USP controlled room temperature 20-25℃ (68-77°F).
Inactive Ingredient
benzyl alcohol, carbomer homopolymer type C 980NF, cholesterol, isopropyl myristate, polysorbate 80, propylene glycol, purified water, soybean lecithin, tocopherol.
Package Label. Principal Display Panel
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