SUPER MAX BARRIER CREAM- white petroleum, zinc oxide cream

Super Max Barrier Cream by

Drug Labeling and Warnings

Super Max Barrier Cream by is a Otc medication manufactured, distributed, or labeled by gentell inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUPER MAX BARRIER CREAM 
white petroleum, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61554-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	50 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61554-700-01	113.4 g in 1 TUBE; Type 0: Not a Combination Product	11/13/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/13/2014

Labeler - Gentell LLC (170967876)

Establishment
Name	Address	ID/FEI	Business Operations
gentell inc		170967876	manufacture(61554-700)