Label: ADVANCED PETROLATUM- petrolatum ointment

  • NDC Code(s): 42213-042-05, 42213-042-28, 42213-042-80
  • Packager: Ultra Seal Corporation
  • 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 November 14, 2018

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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

    image description

  • INGREDIENTS AND APPEARANCE
    ADVANCED PETROLATUM 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-042
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42213-042-80144 in 1 BOX04/05/2011
    1NDC:42213-042-055 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:42213-042-2828 g in 1 TUBE; Type 0: Not a Combination Product04/05/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/05/2011
    Labeler - Ultra Seal Corporation (085752004)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(42213-042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avatar Corporation103338687manufacture(42213-042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation944090448pack(42213-042)
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