Label: ALOE VESTA- petrolatum ointment

  • NDC Code(s): 53329-773-14, 53329-773-18
  • Packager: Medline Industries, LP
  • 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 August 25, 2023

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  • Active ingredient

    White petrolatum 43% w/w

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects minor cuts, scrapes, burns
    • temporarily protects and helps relieve chapped or cracked skin and lips
  • Warnings

    For external use only.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    do not get in eyes

    Stop use and ask a doctor if

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

    Keep out of reach of children.

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

  • Directions

    • apply as needed
  • Other information

    • storage conditions: store at 59°F-86°F (15°C-30°C)
  • Inactive ingredients

    aloe barbadensis leaf juice, DMDM hydantoin, glycerin, hydroxylated lanolin, iodopropynyl butylcarbamate, magnesium sulfate, mineral oil, ozokerite wax, PEG-30 dipolyhydroxystearate, sorbitan sesquioleate, steareth-20, water

  • Manufacturing Information

    Manufacture for Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA with foreign and domestic materials

    www.medline.com

    1-800-MEDLINE

    REF: 324908

    V1 RE21AXQ

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    ALOE VESTA 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-773
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM43 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HYDROXYLATED LANOLIN (UNII: EOI0B9800C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-773-1456 g in 1 TUBE; Type 0: Not a Combination Product09/30/202006/30/2025
    2NDC:53329-773-18226 g in 1 TUBE; Type 0: Not a Combination Product09/30/202008/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/30/202008/31/2025
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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