Active Ingredient(S)
Lidocaine 5%
Tattoo Numbing
FDA Label NDC 84787-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Nuoyiyan Technology Co., Ltd. for the product Tattoo Numbing (NDC 84787-001). 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(s), purpose, use, safe notice, do not use, when using, stop use and consult a doctor, 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
Use
For temporary relief of local discomfort, itching, pain,soreness or burning of the skin
Safe Notice
1. Avoid prolonged exposure to sunlight or UV rays after applying the cream.
2. Use caution when applying the cream near or around sensitive areas, such asthe face or genitals.
3. Avoid contact with eyes, mouth, and other sensitive areas.4. Not recommended for use on broken or irritated skin.
Do Not Use
When Using
1.Conduct a patch test before use to check for allergic reactions or skin sensitivities.
2.Avoid contact with eyes.
3.lf this happens, rinse thoroughly with water.
Stop Use And Consult A Doctor
If irritation, redness, or swelling persists or increases.
-lf you experience any unexpected or severe side effects.
- Do not exceed the recommended daily dosage unless directed by a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Usage Directions
1. Clean the tattooed area with mild soap and water and dry.
2.Apply a layer of tattoo numbing cream evenly to the desired area.
3. To enhance the anesthetic effect, cover the tattooed area with plastic wrapor cling film for about 30 minutes.
4. Remove the cling film and wipe off any excess numbing cream with a cleantissue.
Storage And Handling
Store between 15-30℃(59-86 F ).
-Avoid freezing and excessive heat above 40℃(104 F ).
Inactive Ingredients
Water, Propylene Glycol, Glycerin, Carbomer Homopolymer, Unspecified Type,Edetate Disodium Anhydrous, Hydroxyacetophenone,1,2-Hexanediol, Tocopherol,Mentha arvensis Leaf, Chrysanthemum Indicum Top, Purslane, Polyoxyl 40Hydrogenated Castor Oil.
* Please review the disclaimer below.
