Label: PETROLEUM- white petrolatum jelly

  • NDC Code(s): 37808-960-18, 37808-960-27, 37808-960-54
  • Packager: H-E-B
  • 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, 2022

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  • Active ingredient

    White Petrolatum, USP (100%)

  • Purpose

    Skin Protectant

  • Use

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash
    • helps seal out wetness
  • Warnings

    For external use only

  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • When using this product

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

    • condition worsens
    • systems last longer than 7 days or clear up and occur again within a few days
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area, and allow to dry
    • apply product liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when  exposure to wet diapers may be prolonged
  • INACTIVE INGREDIENT

    None

  • Questions?

    1-888-593-0593

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: H-E-B, SAN ANTONIO, TX 78204

    Made in the USA with US and foreign components

    We hope you are satisfied with this product.  If not, we will cheerfully refund your money.

  • principal display panel

    HILL COUNTRY ESSENTIALS

    100% Pure Petroleum Jelly

    White Petrolatum

    Skin Protectant

    Unscented

    NET WT 2.5 OZ (71 g)

    image description

  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-960
    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:37808-960-1871 g in 1 TUBE; Type 0: Not a Combination Product07/15/2015
    2NDC:37808-960-54106 g in 1 JAR; Type 0: Not a Combination Product07/15/2015
    3NDC:37808-960-27369 g in 1 JAR; Type 0: Not a Combination Product07/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/15/2015
    Labeler - H-E-B (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-960)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-960)
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