Label: ROYAL PETROLEUM JELLY BABY FRESH SCENT BLUE- 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 January 29, 2020

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  • Active Ingredient

    White Petrolatum (99.9% w/w)

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects minor cuts, scrapes, burns
    • temporarily protects and helps relieve chapped or cracked skin
    • helps protect from effects of wind and cold weather
    • helps treat and prevent diaper rash
    • helps seal out wetness
  • Warnings

    • FOR EXTERNAL USE ONLY
  • When using this product

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

    • condition worsens
    • symptoms last for more than 7 days or clear up and occur again within a few day
  • Do not use on

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

    Fragrance

  • PRINCIPAL DISPLAY PANEL

    Package LabelPackage Label

  • INGREDIENTS AND APPEARANCE
    ROYAL PETROLEUM JELLY BABY FRESH SCENT BLUE 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51328-1021
    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:51328-1021-3226 g in 1 JAR; Type 0: Not a Combination Product10/10/2016
    2NDC:51328-1021-5368 g in 1 JAR; Type 0: Not a Combination Product10/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/10/2016
    Labeler - Royal Exports (650621381)
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Safety

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