Label: SOOTHE AND COOL- white petrolatum ointment

  • NDC Code(s): 53329-067-04
  • 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 December 14, 2022

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  • Active ingredient

    White Petrolatum 93.5% w/w

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin or minor skin irritation associated with diaper rash and helps seal out wetness
    • helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips
    • temporarily protects minor cuts, scrapes, and burns
  • 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.

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

  • Directions

    • apply as needed
  • Other information

    • Protect from freezeing. Avoid excessive heat.
  • Inactive ingredients

    Corn Oil, Light Mineral Oil, Retinyl Palmitate (Vitamin A Palmitate), Ergocalciferol (Vitamin D)

  • Manufacturing Information

    Manufactured for: Medline Industries, Inc.

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA

    www.medline.com

    1-800-MEDLINE

    REF: MSC095094

    RD19ULI

  • Package Label

    label 067

  • INGREDIENTS AND APPEARANCE
    SOOTHE AND COOL 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-067
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM935 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ERGOCALCIFEROL (UNII: VS041H42XC)  
    CORN OIL (UNII: 8470G57WFM)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-067-04113 g in 1 TUBE; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01601/01/2007
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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