Label: UNIVERSAL BABY FRESH SCENT PETROLEUM- white petroleum 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 February 8, 2013

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  • ACTIVE INGREDIENT

    Active ingredient

    White Petrolatum USP (99.9 %)

  • 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 BABY FRESH SCENT PETROLEUM
    SKIN PROTECTANT
    NET WT. 13 OZ (368 g)

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    UNIVERSAL BABY FRESH SCENT PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.99 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-006-19226 g in 1 JAR
    2NDC:52000-006-2045 g in 1 JAR
    3NDC:52000-006-21100 g in 1 JAR
    4NDC:52000-006-22113 g in 1 JAR
    5NDC:52000-006-23170 g in 1 JAR
    6NDC:52000-006-24198 g in 1 JAR
    7NDC:52000-006-25283 g in 1 JAR
    8NDC:52000-006-26368 g in 1 JAR
    9NDC:52000-006-27450 g in 1 JAR
    10NDC:52000-006-28500 g in 1 JAR
    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(52000-006)
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