Label: PETROLATUM cream

  • NDC Code(s): 33992-0499-1
  • Packager: Greenbrier International, Inc.
  • 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 February 4, 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), glycerine, glyceryl monostearate, PEG 100 stearate, stearic acid, ceteareth 20, triethanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, tocopheryl acetate, disodium EDTA

  • Principal Display Panel - Petroleum Jelly Tube Label

    ASSURED™

    Vitamin E Enriched

    Creamy
    PETROLEUM
    JELLY

    Skin Softener

    For Dry Skin

    Absorbs Quickly

    Compare to active ingredient of
    Vaseline    ® Deep Moisture™

    Net Wt 3 oz (85g)

    NDC # 33992-0499-1

    Principal Display Panel - Petroleum Jelly Tube Label
  • INGREDIENTS AND APPEARANCE
    PETROLATUM 
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0499
    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)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0499-185 g in 1 TUBE; Type 0: Not a Combination Product02/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/04/2019
    Labeler - Greenbrier International, Inc. (610322518)
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