Active Ingredients
Lidocaine 4%
Plum Smooth Plumb Numb Gelee Gel
FDA Label NDC 49911-884
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Companies, Inc. for the product Plum Smooth Plumb Numb Gelee (NDC 49911-884). 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 ingredients, purpose, uses, directions, warnings, do not use, inactive ingredients, distributed by:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Uses
For the temporary relief of discomfort and pain
Directions
Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily
Warnings
For external use only
Avoid contact with eyes
Do Not Use
In large quantities, particularly over raw surfaces or blistered areas
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine
Distributed By:
Universal Companies, Inc.
Abingdon, VA 24210
Plum Smooth Plumb Numb Gelee 1Oz/28.35G
Plumsmoothlabel (Plumsmooth)
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