Label: ROYAL PETROLEUM 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 November 26, 2018

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  • Active Ingredient

    White petrolatum (100 % w/w)

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects minor cuts, scrapes, burns and sunburn
    • temporarily protects and helps relieve chapped or cracked skin
    • helps protect from the drying 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 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
  • 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

    None

  • PRINCIPAL DISPLAY PANEL

    Package Labelprincipal Display Label

  • INGREDIENTS AND APPEARANCE
    ROYAL PETROLEUM JELLY 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51328-1010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51328-1010-3226 g in 1 JAR; Type 0: Not a Combination Product10/10/2016
    2NDC:51328-1010-5368 g in 1 JAR; Type 0: Not a Combination Product10/10/2016
    3NDC:51328-1010-4283 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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