BABY PETROLEUM (PETROLATUM) JELLY [WALGREEN COMPANY]

BABY PETROLEUM (PETROLATUM) JELLY [WALGREEN COMPANY]
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NDC 0363-0731-13
Set ID e79f2bc2-e53b-4d01-9f9b-d9bd5c3b230d
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active ingredient

    White Petrolatum USP (100%)

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    • helps treat and prevent diaper rash

    • protects chafed skin due to diaper rash

    • helps seal out wetness

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • WHEN USING

    When using this product do not get into eyes.

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    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

    Inactive ingredient

    Fragrance

  • QUESTIONS

    Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    Package/Label Principal Display Panel

    Baby Petroleum Jelly

    Skin Protectant

    Fresh Scent

    Compare to Vaseline® Baby Petroleum Jelly

    NET WT 13 OZ (368 g)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    BABY PETROLEUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0731-13368 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/17/2014
    Labeler - Walgreen Company (008965063)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(0363-0731)

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