Active Ingredient
Lidocaine 5%
Ophyte Tattoo Numbing Cream
FDA Label NDC 83887-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Changsha Beiliang E-commerce Co., Ltd for the product Ophyte Tattoo Numbing Cream (NDC 83887-002). 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
Local Anesthetic
Use
For temporary relief of local and anorectal itching, discomfort, and inflammation associated with anorectal disorders.
For temporary relief of pain, burning, and soreness.
Warnings
lf symptoms worsen or do notimprove within 7 days, seek medicaadvice.
Do not exceed the recommendeodaily dosage without doctor's
instruction.
Consult a doctor immediately if bleeding occurs.
Do not insert this product into the rectum using fingers or any applicator.
Some people may be allergic to the ingredients.Discontinue use and consult a doctor if symptoms persist or worsen,including redness,
irritation, swelling, or pain.
Note: Discontinue use and consult a
doctor if symptoms persist or
worsen, including redness, irritation.
swelling, or pain due to possible
allergies to product ingredients
Do Not Use
Some people may be allergic tothe ingredients. Discontinue use andconsult a doctor if symptoms persistor worsen,including rednessirritation,swelling,or pain.
When Using
If symptoms worsen or do not improve within 7 days, seek medicaladvice.Do not exceed the recommended daily dosage without doctor'sinstruction.Consult a doctor immediately if bleeding occurs.
Do not insert this product into the rectum using fingers or any applicator.
Some people may be allergic to the ingredients. Discontinue use and consult a doctor if symptoms persistor worsen,including redness,irritation,swelling,or pain.
Stop Use
Discontinue use and consult adoctor if symptoms persist orworsen, including redness, irritation,swelling, or pain due to possibleallergies to product ingredients.
Ask Doctor
Discontinue use and consult a doctor if symptoms persist or worsen, including redness, irritation. swelling, or pain due to possible
allergies to product ingredients
Keep Oot Of Reach Of Children
This package is child-resistant.Keep out of reach of children
Directions
Adults: When practical, cleanse theaffected area with mild soap andwarm water, and rinse thoroughlyGently dry by patting or blotting withtoilet tissue or a soft cloth beforeapplication of this product.
Other Information
Keep away from direct sunlight orheat.
Store at room temperaturebetween 15°C and 30°C(59°F-86°F).
This package is child-resistant.Keep out of reach of children. In case of accidental overdose oringestion, call a doctor or poisoncontrol center immediately. Do not use this product if the sealis broken or missing.
Inactive Ingredients
Vitamin E Allantoin, Mineral Oil.Dimethicone,MethylparabenPropylparaben, Petrolatum, IPBCDiazolidinyl Urea, Glycerin,Cetostearyl Alcohol, IsopropylMyristate, Propylene Glycol,Ammonium,Methacrylate, PurifiedWater, Laurocapram, Steareth-2.Steareth-21 Rose Oil
Principal Display Panel
001 (30g)
002 (50g)
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004 (100g)
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