Active Ingredient(S)
Lidocaine 4%
Tattoo Cream
FDA Label NDC 84322-004
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 Gaoye E-commerce Co., Ltd for the product Tattoo Cream (NDC 84322-004). 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, warnings, 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
Purpose
External Analgesic
Use
For temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation
Warnings
• For External Use Only
• Pregnant or breastfeeding, ask a health professional before use.
• In case of accidental overdose, contact a doctor or Poison Control Center immediately.
• Seal is broken or missing.
Do Not Use
• Pregnant or breastfeeding, ask a health professional before use.
• In case of accidental overdose, contact a doctor or Poison Control Center immediately.
• Seal is broken or missing.
Otc - When Using
Do not exceed the recommended daily dosage unless directed by a doctor. Certain persons can develop allergic
reactions to ingredients in this product. Do not put this product into the rectum by using fingers or any medical
device or applicator.
Otc - Stop Use
The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical attention immediately.
Directions
Perform a patch test on the back of your hand before using it to check for skin
sensitivity.When practical, cleanse the affected area with mild soap and warm water and
rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before
application of this product.
Apply up to 2 times a day.
Other Information
Keep away from direct sunlight or heat
Store in room temperature (59-860F / 15-300C)
Inactive Ingredients
WATER PROPYLENE GLYCOL, CARBOMER, GLYCERIN, DISODIUM EDTA. HYDROXY-ACETOPHENONE
Package Label - Principal Display Panel
Label (Label)
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