Label: BABYFRESH PETROLEUM JELLY- petrolatum jelly

  • NDC Code(s): 61734-050-03, 61734-050-04, 61734-050-05, 61734-050-06
  • Packager: Delon Laboratories (1990) Ltd
  • 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 October 20, 2022

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

  • Active Ingredient



    White Petrolatum USP (99.7%)

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects minor:
      • cuts
    • scrapes
    • burns

    • temporarily protects and helps relieve chapped or cracked skin and lips
    • helps protect from the drying effects of wind and cold weather
  • 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

    fragrance

  • Delon Baby Fresh Petroleum Jelly 13 oz (368 g)

    Delon Baby Fresh Petroleum Jelly 13oz

  • Eboline Baby Fresh Petroleum Jelly 13 oz (368 g)

    Eboline Baby Fresh Petroleum Jelly 13oz

  • INGREDIENTS AND APPEARANCE
    BABYFRESH PETROLEUM JELLY 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61734-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61734-050-03368 g in 1 JAR; Type 0: Not a Combination Product05/07/201005/31/2024
    2NDC:61734-050-04212 g in 1 JAR; Type 0: Not a Combination Product05/07/201007/31/2023
    3NDC:61734-050-0590 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/04/201412/04/2014
    4NDC:61734-050-06170 g in 1 JAR; Type 0: Not a Combination Product02/14/201911/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/07/201005/31/2024
    Labeler - Delon Laboratories (1990) Ltd (248364184)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delon Laboratories (1990) Ltd243387722label(61734-050) , pack(61734-050) , manufacture(61734-050)