Label: PETROLEUM ORIGINAL- white petrolatum jelly

  • NDC Code(s): 76176-065-01
  • Packager: Ningbo Liyuan Daily Chemical Products Co., 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 August 1, 2020

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

  • Drug Facts Active Ingredients

    White Petrolatum USP 100 percent

  • Purpose

    skin protectant

  • USE:

    Helps treat and prevent diaper rash. Helps seal out wetness.

  • Warnings:

    For external use only.

    Do not apply over deep puncture wounds, infections, or lacerations.

    If redness or swelling develops, consult a physician promptly.

  • Keep out of reach of children

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

  • Directions

    Apply liberally, as often as necessary.

  • INACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PETROLEUM ORIGINAL 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-065
    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:76176-065-01170 g in 1 JAR; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2020
    Labeler - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)
    Registrant - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(76176-065)