Label: PETROLATUM JELLY WITH LAVENDER- petrolatum jelly

  • 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 29, 2018

If you are a consumer or patient please visit this version.

  • DRUG FACTS

    White Petrolatum 99.9%

  • Purpose

    Skin Protectant

  • Uses

    • provides relief to dry skin and lips
    • offers soothing protection for minor burns
    • provides protection for skin from wind burn and chapping
  • Warnings: FOR EXTERNAL USE ONLY

    Do not use on

    • deep or puncture wounds
    • infections
    • lacerations
  • Stop Use and ask a doctor if

    • redness or swelling develops
  • Keep out of reach of children

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

    • apply as needed
  • Inactive Ingredient

    fragnance

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    PETROLATUM JELLY WITH LAVENDER 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-0207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-0207-2226 g in 1 JAR; Type 0: Not a Combination Product06/21/2016
    2NDC:52410-0207-4368 g in 1 JAR; Type 0: Not a Combination Product06/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/21/2016
    Labeler - SHIELD LINE LLC (078518916)