Label: SOOTHE AND COOL PROTECT- petrolatum jelly

  • NDC Code(s): 53329-993-04
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL

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 December 15, 2022

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  • Active Ingredient (in each gram)

    White Petrolatum 100%

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects minor
    • cuts
    • scrapes
    • burns
    • temporarily protects and helps relieve chapped or cracked skin and lips
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    Stop use and ask a doctor if

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

    When using this produc

    • do not get into eyes

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    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

    none

  • Other information

    • stor at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF)
    • avoid excessive heat and humidity
  • Manufacturing Information

    Manufactured for: Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    www.medline.com

    1-800-MEDLINE

    MSC095034

    RE19ULI

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    SOOTHE AND COOL PROTECT 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-993
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-993-04113 g in 1 TUBE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01604/01/2019
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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