Otc - Active Ingredient
Lidocaine 5%, Epinephrine 1%
Tattoo Cream
FDA Label NDC 85942-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Perfso (hk) Co., Limited for the product Tattoo (NDC 85942-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - 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
Otc - Purpose
Topical pain relief and wound repair
Indications & Usage
As directed by the physician.
Usable RangeMcro Needle Pain Tattooing Body Piercing,Laser Tattoo Removal, Laser Hair Removal, Waxing,Permanent Cosmetics.
Warnings
n/a
Otc - Do Not Use
Do not use:Under 18 must be accompanied by an adult
Otc - When Using
Keep away from your eyes when using this product. If in contact with eyes, wash eyes thoroughly with water.
Otc - Stop Use
Stop using and ask your doctor if you have any irritation or rash. These may be signs of a serious illness.
Please stay away from children.If you swallow, seek medical attention immediately
Otc - Keep Out Of Reach Of Children
Keep out of reach for children.
Dosage & Administration
Usage
1. Rotate the nozzle with the top of the cap. Resealed after use.
2.Wash the skin with soap and warm water making sure It's clean and free of bacteria.
3.Put the anesthetic evenly on the skin(1/8 inch or2-3mm thick), and cover the skin with a plastic wrap for 50-60 minutes toachieve 6-10 hours of numbness.
4.Before starting the operation,Remove the cream and let the skin breathe for 5-10minutes before proceeding with the work.When using this product, please control the room temperatue at 28C ~30C,so that the skin can absorb the cream quicker.
Storage And Handling
Storage
Store above Zero and Below30°℃.
Protect from Light.
Do not freeze.
Inactive Ingredient
Prilccaine, Carbomer, Propylene Glycol, Triethanolamine
Package Label.Principal Display Panel
85942-001-01 (85942 001 01)
* Please review the disclaimer below.
