Active Ingredients:
Allantoin 2.00%
Lidocaine 4.00%
Petrolatum 30.00%
Elite Pain Relief
FDA Label NDC 69418-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meds Direct Rx, Inc. for the product Elite Pain Relief (NDC 69418-004). 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:, otc - purpose, uses:, warnings:, otc - keep out of reach of children, directions:, inactive ingredients:, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Topical Anesthetic
SkinProtectant
Uses:
Temporarily protects minor cuts, scrapes and burns
Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations
Warnings:
•For external use only.
•Avoid contact with eyes.
•Stop use and ask a doctor if condition worsens, or symptoms last more than 7 days, or clear up and occur again within a few days.
•Do not use on deep or puncture wounds, animal bites, or serious burns.
•If pregnant or breast feeding, contact physician prior to use.
• Do not use in large quantities, particularly over raw surfaces or blistered areas.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Directions:
•Clean and dry affected area
•Remove mesh from backing and apply to affected area
•Use only one mesh at a time, and maximum of 4 mesh/day
• Leave mesh on affected area for up to 8 hours
•Do not use mesh for longer than 5 consecutive days
•Children under 12 should consult physician prior to use
Inactive Ingredients:
Vitamin E, Onion Extract, Dihydroxyaluminum Aminoacetate, Disodium Edetate, Gelatin, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Polyacrylate, D-Sorbitol, Tartaric Acid, Urea, Sodium Carboxymethylcellulose
Other
Store below 25° degrees. Avoid direct sunlight.
Manufactured For:
Meds Direct Rx, Inc
882 Third Avenue 1Oth Floor Suite 1000
Brooklyn, NY 11232
Questions or Comments call 855-480-MEDS
Made in China
Package Labeling
Elitefront (Elitefront)
Eliteback (Eliteback)
* Please review the disclaimer below.
