Painless Tattoo Numbing Liquid
FDA Label NDC 54723-019

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sambria Pharmaceuticals, Llc for the product Painless Tattoo Numbing (NDC 54723-019). 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 drug facts, active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Lidocaine HCL 4.0% 

Purpose

External Analgesic

Uses

For temporary relief of pain and itching.

Warnings

For external use only.

Flammable: Do not use near heat, flame, or while smoking.

Do not useon wounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

When using this productuse only as directed. Keep away from face to avoid breathing it. Avoid contact with eyes. Do not store at temperatures above 120°F. Do not puncture or incinerate.

Stop use and ask doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of childrenand pets If swallowed get medical help or contact a Poison Control Center right away.

Directions

Shake well. Do not spray on face. Adults and children 12 years of age and over: Clean and dry affected area, apply to affected area not more than 3 to 4 times daily. Children 12 years of age or younger: ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Aqua (Deionized Water), Dimethyl Sulfone, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Propylene Glycol, SD Alcohol 40-B

Product Label

Image Description (Image 019)

Image Description (Image 019)

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