SUPER MAX BARRIER CREAM- white petroleum, zinc oxide cream 
gentell inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Super Max Barrier Cream

Warnings and precautions

Keep out of reach of children

Purpose

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

Active Ingredient

Petrolatum

Zinc Oxide

Dosage & administration

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

Warnings

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

Mineral Oil

Castor oil

DMDM Hydantoin

Aloe Vera

Vitamin A Palmitate

vitamin D

Peruvian Balsam

Indication & Usage

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

Principal Label

4oz Tube

SUPER MAX BARRIER CREAM 
white petroleum, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61554-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM50 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP) 16 g  in 100 g
CASTOR OIL (UNII: D5340Y2I9G) 16 g  in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW) 0.2 g  in 100 g
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) 0.1 g  in 100 g
CHOLECALCIFEROL (UNII: 1C6V77QF41) 0.4 g  in 100 g
BALSAM PERU (UNII: 8P5F881OCY) 1 g  in 100 g
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.3 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61554-700-01113.4 g in 1 TUBE; Type 0: Not a Combination Product11/13/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/13/2014
Labeler - gentell inc (170967876)
Establishment
NameAddressID/FEIBusiness Operations
gentell inc170967876manufacture(61554-700)

Revised: 5/2021
Document Id: c36a6fd0-bf47-fc28-e053-2a95a90a22d9
Set id: b5599e1b-0cb1-7baa-e053-2a95a90aabeb
Version: 2
Effective Time: 20210528
 
gentell inc