Super Max Barrier Cream

Manufacturer
Gentell LLC | gentell inc
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:23:48

Label at a glance#

ProductSuper Max Barrier Cream
Active ingredientZINC OXIDE, PETROLATUM
Label structure10 sections

Label contents#

Full prescribing information#

Indications & Usage

RECENT MAJOR CHANGES SECTION

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.

Warnings and precautions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Purpose

OTC - PURPOSE SECTION

Gentell SuperMax Moisture Barrier Cream protects healthy and intact skin from breaking down during compromised skin conditions.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum

Zinc Oxide

Dosage & administration

DOSAGE & ADMINISTRATION SECTION

Clean the affected area, and dry thoroughly. Apply SuperMax liberally and as often as necessary, especially whenprolonged exposure to moisture is anticipated.

Warnings

WARNINGS SECTION

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

inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil

Castor oil

DMDM Hydantoin

Aloe Vera

Vitamin A Palmitate

vitamin D

Peruvian Balsam

Indication & Usage

INDICATIONS & USAGE SECTION

Gentell SuperMax Moisture Barrier Cream protects healthy and intact skin from breaking down during compromised skin conditions

Principal Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Super Max OintmentSuper Max Ointment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Super MaxSuper Max

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61554-700-01Super Max Barrier Cream113.4 g in 1 TUBECREAM113.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61554-700SUPER MAX BARRIER CREAM (WHITE PETROLEUM, ZINC OXIDE) CREAM [GENTELL LLC]3Legacy NDC, 1 package rows20241010_b5599e1b-0cb1-7baa-e053-2a95a90aabeb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-70061554-700-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
23fcb2b7-85e8-c0b5-e063-6394a90af55ab5599e1b-0cb1-7baa-e053-2a95a90aabeb2024-10-08WarningsExact identifier
spl id: 23fcb2b7-85e8-c0b5-e063-6394a90af55a
spl set id: b5599e1b-0cb1-7baa-e053-2a95a90aabeb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.