The following Structured Product Label (SPL) was submitted to the FDA by Gentell Llc for the product Super Max Barrier Cream (NDC 61554-700). 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 indications & usage, warnings and precautions, purpose, active ingredient, dosage & administration, warnings, inactive ingredients, indication & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
SuperMax Moisture Barrier Cream protects healthy and intact skin from breaking down during compromised skin conditions.
Directions: Clean the affected area, and dry thoroughly. Apply SuperMax liberally and as often as necessary, especially when prolonged exposure to moisture is anticipated.
Keep out of reach of children
Gentell SuperMax Moisture Barrier Cream protects healthy and intact skin from breaking down during compromised skin conditions.
Petrolatum
Zinc Oxide
Clean the affected area, and dry thoroughly. Apply SuperMax liberally and as often as necessary, especially whenprolonged exposure to moisture is anticipated.
For external use only
Avoid all contact with eyes
If condition fails to improve after seven days, consult a physiian
Keep out of reach of children
If swallowed, seek medical attention or call a Poison Control Center immediately
Mineral Oil
Castor oil
DMDM Hydantoin
Aloe Vera
Vitamin A Palmitate
vitamin D
Peruvian Balsam
Gentell SuperMax Moisture Barrier Cream protects healthy and intact skin from breaking down during compromised skin conditions
* Please review the disclaimer below.
