Active Ingredient
5% LIDOCAINE
Oudetas Lidocaine Cream
FDA Label NDC 87408-022
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Jingliang Cosmetics Co., Ltd. for the product Oudetas Lidocaine Cream (NDC 87408-022). 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, ask a doctore before use, keep out of reach of children, purpose, stop use, when using, inactive ingredients, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask A Doctore Before Use
If you are pregnant or breastfeeding, consult a healthcare provider before use.
Keep Out Of Reach Of Children
If swallowed, get medical help.
Purpose
Local Analgesic
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.
When Using
Only take the recommended daily dosage unless otherwise instructed by a doctor.
Some individuals may experience allergic reactions to the ingredients contained in this product.
Never put it into the rectum by using the finger or any medical device.
Inactive Ingredients
Tocopheryl Acetate
Emu Oil
Propylene Glycol
Arnica
Glycerin
Menthol
Aesculus Hippocastanum (Horse Chestnut) Extract
Lecithin (Soybean)
Curcuma Longa Extract
Aqua (Water)
Directions
For adults: Cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
Apply up to 6 times a day.
For children under 12 years of age: Consult a doctor
Warnings
For external use only.
Uses
For temporary mild local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders and anorectal inflammation.
Do Not Use
Pregnant or breastfeeding, ask a health professional before use.
If there is any allergic reaction to this product.
In case of accidental overdose, get medical help, or contact the poison control center immediately.
Package Label.Principal Display Panel
Brand: Oudeate
Name: LIDOCAINE Cream
Size: 60 g
* Please review the disclaimer below.
