Active Ingredient
Lidocaine 4% - Local anesthetic for 8 hours
Tattoo Numbing Cream
FDA Label NDC 85284-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bloomwell Gardens Llc for the product Tattoo Numbing Cream (NDC 85284-001). 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, purpose, dosage & administration, useage before tattooing, do not use, attention, important, other ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Dosage & Administration
- Due to the different in temprature and skin type, the duration of the numbness effect will be different.
- First test in a small area is recommended to ensure the best numbness effect.
Useage Before Tattooing
1. Clean hands and treatment are with mild soap and warm water. Rinse thoroughly and gently pat dry.
2. Apply a thick numbing cream to the treatment area, making sure to cover the tattoo and its surroundings.
3. Wrap tightly with plastic wrap and wait for 40-60 munutes.
4. Wipe away any exceess residue and allow addtional 15-25 minutes for the numbing effect to reach its peak. Then you can begin the tattoo procedure.
Do Not Use
- If you are pregnant or nursing, consult with your healthcare provider before use.
- The product seal is broken or missing.
- Do not use on broken or irritated skin.
- People who are allergic to the ingredients in this product.
Attention
- Do not get into eyes.
- Do not swallow.
- Do not exceed the recommended dosage unless directed by a doctor.
- Do not insert this product into the recturm.
Important
Keep out of reach of children.
Other Ingredients
Water, Glycerin, Butyllene Glycol, Butter Oil, Squalane, Dimethicone, Menthol, Borneol, Xanthan Gum.
* Please review the disclaimer below.
