Label: UNIVERSAL PURE PETROLEUM- white petroleum jelly

  • NDC Code(s): 52000-005-19, 52000-005-20, 52000-005-21, 52000-005-22, view more
    52000-005-23, 52000-005-24, 52000-005-25, 52000-005-26, 52000-005-27, 52000-005-28
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL

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 November 4, 2022

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  • ACTIVE INGREDIENT

    Active ingredient

    White Petrolatum USP (100 %)

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    • For the temporary protection of minor cuts, scrapes, burns and sunburn.
    • Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.
  • WARNINGS

    Warnings

    For External Use Only.

    Do not use over deep or puncture wounds, infections or lacerations. Ask a doctor.

    When using this product avoid contact with eyes.

    Stop use and ask doctor if condition worsens or does not improve within 7 days.

    Keep out of reach of children if swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply product as liberally, as often as necessary.

  • INACTIVE INGREDIENT

    Inactive ingredients

    None

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    UNIVERSAL PURE PETROLEUM JELLY
    SKIN PROTECTANT
    NET WT. 13 OZ (368 g)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL 100% PURE PETROLEUM JELLY Net Wt. 8 fl. oz. (250g) 8 onzas

  • INGREDIENTS AND APPEARANCE
    UNIVERSAL PURE PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-005
    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:52000-005-19226 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    2NDC:52000-005-2045 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    3NDC:52000-005-21100 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    4NDC:52000-005-22113 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    5NDC:52000-005-23170 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    6NDC:52000-005-24198 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    7NDC:52000-005-25283 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    8NDC:52000-005-26368 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    9NDC:52000-005-27450 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    10NDC:52000-005-28500 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/06/2013
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-005)
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