Label: MEDLINE- white petrolatum ointment

  • NDC Code(s): 53329-188-44
  • 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 September 27, 2023

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  • Active ingredient

    White petrolatum 93.4% w/w

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects minor cuts, scrapes and burns
    • helps prevent and 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 into eyes

    Stop use and ask a doctor if

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

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    • for skin protection: apply as needed
  • Other information

    • store at controlled room temperature
    • protect from freezing
    • avoid excessive heat
  • Inactive ingredients

    lavender oil, light mineral oil, vitamin A palmitate (retinyl palmitate), vitamin D

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in India.

    www.medline.com
    1-800-MEDLINE (633-5463)

    REF: MSC095094

    V3 RG23GZP

  • Package Label

    Label V3 RG23GZP

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM93.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN D (UNII: 9VU1KI44GP)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-188-44113 g in 1 TUBE; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01608/01/2023
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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