Label: PETROLATUM JELLY- petrolatum jelly

  • NDC Code(s): 77338-101-03, 77338-101-05
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • 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 12, 2023

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  • Active Ingredient

    White Petrolatum (99.9% 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 drying effect of wind and cold weather
    • helps treat and prevent diaper rash
    • help seal out wetness
  • Warnings

    FOR EXTERNAL USE ONLY

  • When using this product

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

    • condition worsens
    • symptoms last for more than 7 days or clean up and occur again in 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

    Fragrance

  • Package Label

    Principal Display and Drug Fact PanelPrincipal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    PETROLATUM JELLY 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-101
    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:77338-101-03226 g in 1 JAR; Type 0: Not a Combination Product01/01/2023
    2NDC:77338-101-05368 g in 1 JAR; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/11/2016
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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