Label: MEDLINE- white petrolatum jelly

  • NDC Code(s): 53329-150-44
  • 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 June 1, 2023

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  • Active ingredient

    White petrolatum 100% 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
    • helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
  • 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
    • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary , with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • Other information

    • store at controlled room temperature
    • protect from freezing
    • avoid excessive heat
    • not made with Natural Rubber Latex
  • Inactive ingredients

    none

  • Questions or comments?

    1-800-MEDLINE (633-5463)

    Monday-Friday 9AM-5PM CST

  • 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: MSC095034

    V2 RF23GZP

  • Package Label

    Label V2 RF23GZP

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-150-44113 g in 1 TUBE; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01604/01/2023
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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