Label: PETROLATUM cream

  • NDC Code(s): 33992-0498-1
  • Packager: Greenbrier International, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 17, 2019

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  • Active Ingredient:

    White Petrolatum USP (30 %)

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects minor:
      • cuts
      • scrapes
      • burns
    • temporarily protects and helps relieve chapped or cracked skin
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only.

    Do not use on deep puncture wounds, animal bites and serious burns.

    When using this product,

    do not get into eyes

    Stop use and ask doctor if

    • condition worsens,
    • symptoms last more than 7 days
    • clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply as needed.

  • Inactive ingredients

    water (aqua), glycerin, glyceryl monostearate, PEG-100 stearate, stearic acid, ceteareth 20, trieathanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA

    110781 DISTRIBUTED BY

    GREENBRIER INTERNATIONAL, INC.

    500 VOLVO PARKWAY,

    CHESAPEAKE, VA 23320

    MADE IN INDIA

    Skin Softener

    Hydrates &

    Evens Skin Tone

    COCOA

    BUTTER

    Petroleum Jelly

    C. No. DNH/COS/DNH/130

    1222101976

  • Principal Display Panel - 3 oz Tube Label

    ASSURED™

    Vitamin E Enriched

    Creamy

    COCOA
    BUTTER

    Petroleum Jelly

    Skin Softener

    Hydrates &
    Evens Skin Tone

    Net Wt 3 oz (85g)

    NDC # 33992-0498-1

    Principal Display Panel - 3 oz Tube Label
  • INGREDIENTS AND APPEARANCE
    PETROLATUM 
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0498
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0498-185 g in 1 TUBE; Type 0: Not a Combination Product05/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/17/2019
    Labeler - Greenbrier International, Inc. (610322518)
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