Label: PETROLATUM ointment

  • NDC Code(s): 0404-0042-05, 0404-0042-47
  • Packager: Henry Schein, Inc.
  • 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 January 3, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients White Petrolatum 100%

  • PURPOSE

    Purpose: Skin Protectant

  • INDICATIONS & USAGE

    Temporarily protects minor cuts, scrapes, and burns. Temporarily protects and helps chapped or cracked skin and lips.  Helps protect lips from drying effects fo wind and cold weather.

  • WARNINGS


    For external use only. Do not use in eyes, on puncture wounds, animal bites, or serious burns or for more than one week unless directed by a doctor..

    Stop use and ask a doctor if condition worsens, persists, or recurs.



  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions: Apply as needed

  • INACTIVE INGREDIENT

    Inactive Ingredients: None

  • PRINCIPAL DISPLAY PANEL

    hs petro box

  • INGREDIENTS AND APPEARANCE
    PETROLATUM 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0042-47144 in 1 BOX06/08/2015
    1NDC:0404-0042-055 g in 1 PACKET; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01604/05/201104/01/2025
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(0404-0042)
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