Label: BABY PETROLEUM JELLY- white petrolatum cream

  • NDC Code(s): 57337-076-01, 57337-076-02, 57337-076-03, 57337-076-04
  • Packager: Rejoice International Inc.
  • 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 November 18, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients                      Purpose

    White Petroleum 99.9% ...... skin protectant

  • PURPOSE

    Uses

    temporarily protects and helps relieve chapped or cracked skin and lips

  • 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.

  • INDICATIONS & USAGE

    XtraCare

    100% Pure Petroleum Jelly

    Baby Fresh Scent

  • DOSAGE & ADMINISTRATION

    Directions

    • change and cleanse diaper area, and allow to dry
    • apply product as needed, with each diaper change, especially at bedtime and when exposure to wet diapers may be prolonged
  • WARNINGS

    Warnings

    For external use only

    When using this product do not get into eyes

    See a doctor if condition lasts more than 7 days

    Do not use on

    • deep puncture wounds
    • animal bites
    • serious burns
  • INACTIVE INGREDIENT

    Inactive ingredients fragrance

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    BABY PETROLEUM JELLY 
    white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-076-01113 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
    2NDC:57337-076-02170 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
    3NDC:57337-076-03227 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
    4NDC:57337-076-04368 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/15/2015
    Labeler - Rejoice International Inc. (078741245)
    Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(57337-076)
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