Active Ingredient
LIDOCAINE HCI 3% w/w
Lidocaine Tattoo Wipe Cloth
FDA Label NDC 85055-397
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Md Tattoo Company for the product Lidocaine Tattoo Wipe (NDC 85055-397). 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, uses, warnings, keep out of reach of children, directions, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Uses
• For temporarily relief of pain and itching associated with minor • cuts • burns • sunburns • insect bites • scrapes • and minor skin irritations
Warnings
• For external use only.
Ask a doctor if you have • deep puncture wounds • animal bites • serious burns.
When using this product • do not use in or near the eyes • in case of contact, rinse eyes thoroughly with water • do not apply over large areas of the body or in large quantities.
Stop use and ask a doctor if • condition worsens • irritation or rash appears and lasts for more than 72 hours.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.
Directions
• For adults and Children two years and older: Apply the wipe thoroughly to the affected area. Use up to 3-4 times daily. For best results, allow the area to remain wet for 1-2 minutes.
Inactive Ingredients
• Benzalkonium Chloride, Caprylyl Glycol, Phenoxyethanol, Polysorbate 20, Water.
Principal Display Panel
NUMB
FAST-ACTING
PAIN RELIEVING WIPE
LIDOCAINE INFUSED
Wipe Outz
1 X-LARGE WIPE (8 X 7 IN)
DO NOT FLUSH
Label (Pl 8439)
* Please review the disclaimer below.
