Label: PETROLEUM- white 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 25, 2023

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

  • Active ingredients

    White Petrolatum USP (100%)

  • Purpose

    Skin Protectant

  • Use

    helps protect chapped skin

  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • See a doctor if

    condition lasts more than 7 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

  • Adverse Reactions

    Distributed by Salado Sales, Inc.

    6201 NW H.K. Dodgen Loop Temple, TX 76504

    saladosales.com

  • Principal display panel

    CVP

    100% PURE

    PETROLEUM JELLY

    WHITE PETROLATUM

    SKIN PROTECTANT

    NET WT 3.75 OZ (106 g)

    image description

  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57243-069-54106 g in 1 JAR; Type 0: Not a Combination Product06/04/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/04/2003
    Labeler - Salado Sales, Inc (009830555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(57243-069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(57243-069)