Painless Tattoo 1 Cream
FDA Label NDC 54723-015
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 1 (NDC 54723-015). 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, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzocaine 20%
Purpose
External Analgesic
Uses
For temporary relief of pain and itching due to minor skin irritation.
Warnings
For external use only
Avoid contact with eyes
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.Discontinue use.
Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.
Protect this product from excessive heat and direact sun.
Directions
For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily.
Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.
Inactive Ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin,
Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,
Polyacrylamide, Propylene Glycol,StearicAcid, Triethanolamine.
Product Label
Image Description (Image Tattoo 1)
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