Tattoonumb Cream
FDA Label NDC 54723-030
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 Tattoonumb (NDC 54723-030). 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
Active Ingredient
Lidocaine HCL 4.0% w/w
Purpose
External Analgesic
Uses
For temporary relief of pain and itching.
Warnings
For external use only.
Do not use on wounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.
When using this product use only as directed. Avoid contact with the eyes, rashes, or mucous membranes.
Stop use and ask doctor if condition 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 children and pets If swallowed get medical help or contact a Poison Control Center right away.
Directions
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
Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine
Product Label
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