Label: MEDLINE- white petrolatum ointment

  • NDC Code(s): 53329-146-14, 53329-146-15, 53329-146-16, 53329-146-81
  • 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 16, 2023

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  • Active ingredient

    White petrolatum 98.3% 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
  • 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 or does not improve within 7 days, or clears up and occurs 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

    • for skin protection: apply as needed
  • Other information

    • protect from freezing
    • avoid excessive heat
  • Inactive ingredients

    aloe extract, benzethonium chloride, cholecalciferol (vitamin D), cococaprylate/caprate, corn oil, retinyl palmitate (vitamin A), tocopheryl acetate (vitamin E)

  • Manufacturing information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MSC095380

    V3 Rj22UPK

  • Package Label

    Tube V3 RJ22UPK

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-146
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM983 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-146-1457 g in 1 TUBE; Type 0: Not a Combination Product03/01/2023
    2NDC:53329-146-15198 g in 1 TUBE; Type 0: Not a Combination Product06/01/2023
    3NDC:53329-146-1699 g in 1 TUBE; Type 0: Not a Combination Product05/01/2023
    4NDC:53329-146-8199 g in 1 TUBE; Type 0: Not a Combination Product05/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01603/01/2023
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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