Label: BABY PETROLATUM JELLY- 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 February 24, 2021

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  • Active Ingredient

    White Petrolatum USP (99.9% )

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • helps seal out wetness
  • Warnings: FOR EXTERNAL USE ONLY

    Do not use on

    • deep and punture wounds
    • animal bites
    • serious burns
  • When using this product

    • do not get into eyes
  • Stop Use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clean up and occur again in few days
  • Keep out of reach of children

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

    • apply liberally to clean out diaper rash area
  • Other Information

    • Store at room temperature
  • Inactive Ingredient

    Fragrance

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    BABY PETROLATUM JELLY 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-0206
    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:52410-0206-2226 g in 1 JAR; Type 0: Not a Combination Product06/21/2016
    2NDC:52410-0206-4368 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)
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