Label: SKIN PROTECTANT PETROLATUM- petrolatum ointment

  • 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 February 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Petrolatum 44.28%

  • Purpose

    Skin protectant

  • Uses

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

    For external use only.

    When using this product

    • do not get into eyes In case of contact, flush thoroughly with water.

    Stop use and ask a doctor if

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

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
    • broken skin

    Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

  • Directions

    Apply as needed.

  • Other information

    • Store at room temperature (59°-86°F)
    • Do not use if inner seal is broken or missing
  • Inactive ingredients

    cetostearyl alcohol, microcrystalline wax, mineral oil, and polysorbate 60

  • Questions or comments?

    1-800-697-3329

  • PRINCIPAL DISPLAY PANEL - 454 GM Jar Label

    NDC 69375-0004-54

    Nationwide
    Pharmaceutical

    Skin Protectant
    Petrolatum Ointment

    For dry, cracked or irritated skin

    454 GM (16 OZ)

    PRINCIPAL DISPLAY PANEL - 454 GM Jar Label
  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT PETROLATUM 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69375-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum44.28 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69375-004-54454 g in 1 JAR; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34703/01/2021
    Labeler - Nationwide Pharmaceutical, LLC (079265801)
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