Label: SUPER MAX BARRIER CREAM- white petroleum, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 28, 2021

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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