BABY PETROLEUM JELLY (WHITE PETROLATUM) CREAM [REJOICE INTERNATIONAL INC.]

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BABY PETROLEUM JELLY (WHITE PETROLATUM) CREAM [REJOICE INTERNATIONAL INC.]
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NDC 57337-076-01, 57337-076-02, 57337-076-03, 57337-076-04
Set ID caf568aa-3889-41ff-835e-875bb6d9ca79
Category HUMAN OTC DRUG LABEL
Packager Rejoice International Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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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

    image description

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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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(57337-076)
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