Pain Free Iv Cream
FDA Label NDC 54723-008
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 Pain Free Iv (NDC 54723-008). 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, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
4% Lidocaine
Purpose
External Anesthetic
Uses
For temporary relief of pain and itching due to minor skin irritations.
Warnings
For external use only.
Avoid contact with eyes.
Do not use in large quantities, particularly over raw surface or blistered areas
Stop use and ask doctor if
Condition worsens or if symptons persists more than 7 days or clear up and occur again within a few days. Discontinue use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
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.
Inactive Ingredients
Aqua (Deionized Water), Arnica Montana Floweri Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.
Other Information
Protect this product from excessive heat and direct sun.
Image Description (Image 008)
Question Or Comments
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