Label: SOOTHE AND COOL MOISTURE BARRIER- petrolatum ointment

  • NDC Code(s): 53329-071-14, 53329-071-15, 53329-071-16, 53329-071-96
  • 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 8, 2023

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  • Active ingredient

    White Petrolatum 98.3%

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects minor: cuts, scrapes, burns
    • 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 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
    • 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
  • 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

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MSC095380

    V1 RK21UPK

  • Package Label

    Label V1 RK21UPK

  • INGREDIENTS AND APPEARANCE
    SOOTHE AND COOL MOISTURE BARRIER 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM98.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    ALOE (UNII: V5VD430YW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-071-1456 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
    2NDC:53329-071-15198 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
    3NDC:53329-071-96144 in 1 BOX03/01/2006
    3NDC:53329-071-165 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:53329-071-165 g in 1 PACKET; Type 0: Not a Combination Product03/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01603/01/2006
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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